Trial Outcomes & Findings for Social Safety Learning in the Brain Oxytocin System (NCT NCT05968651)
NCT ID: NCT05968651
Last Updated: 2026-06-11
Results Overview
mean skin conductance responses (SCR) for CS+S stimuli during Extinction
COMPLETED
PHASE2
121 participants
immediately (45 minutes) after receiving drug
2026-06-11
Participant Flow
Participants were recruited from the community via online and print advertisements and through local research volunteer databases.
121 participants were consented and assessed for eligibility. 104 participants were randomized to drug group (10 patients with SAD and 7 healthy participants were excluded due to ineligibility). In the SAD group, 7 did not meet criteria for SAD or SAD was not primary, 3 had active substance use disorders in the past 6 months, 1 had a history of brain lesion, 1 had current psychotherapy, and 1 had past manic episode. In the healthy group, 6 had past depression and 1 had subclinical SAD symptoms.
Participant milestones
| Measure |
Clinical-Placebo
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
28
|
29
|
24
|
|
Overall Study
COMPLETED
|
23
|
28
|
28
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Social Safety Learning in the Brain Oxytocin System
Baseline characteristics by cohort
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
12 Participants
n=6 Participants
|
55 Participants
n=7 Participants
|
|
Age, Continuous
|
22.956522 years
STANDARD_DEVIATION 4.771871 • n=20 Participants
|
24.750000 years
STANDARD_DEVIATION 6.818412 • n=20 Participants
|
25.678571 years
STANDARD_DEVIATION 8.046410 • n=40 Participants
|
24.708333 years
STANDARD_DEVIATION 7.189843 • n=6 Participants
|
24.592233 years
STANDARD_DEVIATION 6.851988 • n=7 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
12 Participants
n=6 Participants
|
48 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
17 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
22 Participants
n=6 Participants
|
83 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
12 Participants
n=6 Participants
|
48 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hawaiian/Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Middle eastern
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native, black
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
9 Participants
n=6 Participants
|
35 Participants
n=7 Participants
|
|
Liebowitz Social Anxiety Scale (LSAS)
|
82.521739 units on a scale
STANDARD_DEVIATION 18.247963 • n=20 Participants
|
82.296296 units on a scale
STANDARD_DEVIATION 17.065067 • n=20 Participants
|
10.464286 units on a scale
STANDARD_DEVIATION 9.073699 • n=40 Participants
|
13.958333 units on a scale
STANDARD_DEVIATION 11.888903 • n=6 Participants
|
46.549020 units on a scale
STANDARD_DEVIATION 38.096705 • n=7 Participants
|
|
Depression Anxiety Stress Scale
|
45.304348 units on a scale
STANDARD_DEVIATION 23.599759 • n=20 Participants
|
32.928571 units on a scale
STANDARD_DEVIATION 23.421941 • n=20 Participants
|
4.714286 units on a scale
STANDARD_DEVIATION 5.083431 • n=40 Participants
|
9.000000 units on a scale
STANDARD_DEVIATION 12.129734 • n=6 Participants
|
22.446602 units on a scale
STANDARD_DEVIATION 24.128629 • n=7 Participants
|
|
skin conductance responses (SCR) to CS- during Acquisition
|
0.041761 microsiemens
STANDARD_DEVIATION 0.102010 • n=20 Participants
|
0.036862 microsiemens
STANDARD_DEVIATION 0.083133 • n=20 Participants
|
0.055211 microsiemens
STANDARD_DEVIATION 0.121996 • n=40 Participants
|
0.067057 microsiemens
STANDARD_DEVIATION 0.153348 • n=6 Participants
|
0.050110 microsiemens
STANDARD_DEVIATION 0.117717 • n=7 Participants
|
|
skin conductance responses (SCR) to CS+ during Acquisition
|
0.037599 microsiemens
STANDARD_DEVIATION 0.095179 • n=20 Participants
|
0.050484 microsiemens
STANDARD_DEVIATION 0.109047 • n=20 Participants
|
0.073121 microsiemens
STANDARD_DEVIATION 0.169627 • n=40 Participants
|
0.078206 microsiemens
STANDARD_DEVIATION 0.157533 • n=6 Participants
|
0.060565 microsiemens
STANDARD_DEVIATION 0.138834 • n=7 Participants
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Extinction Phase
|
-0.30981097 change in BOLD responses
Standard Deviation 1.26938756
|
0.30048434 change in BOLD responses
Standard Deviation 1.18240582
|
-0.13914898 change in BOLD responses
Standard Deviation 1.37320224
|
0.15823593 change in BOLD responses
Standard Deviation 1.17250848
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Extinction Phase
|
-0.54355789 change in BOLD responses
Standard Deviation 1.335981511
|
-0.43311088 change in BOLD responses
Standard Deviation 1.093056486
|
-0.19255644 change in BOLD responses
Standard Deviation 1.431375519
|
-0.76718325 change in BOLD responses
Standard Deviation 1.20337605
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Extinction Phase
|
-0.07399244 change in BOLD responses
Standard Deviation 1.07281373
|
0.063813396 change in BOLD responses
Standard Deviation 1.38005297
|
0.156824376 change in BOLD responses
Standard Deviation 1.295934186
|
0.279316489 change in BOLD responses
Standard Deviation 1.259501388
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase
|
-0.204600375 changes in BOLD responses
Standard Deviation 1.285989133
|
0.106625352 changes in BOLD responses
Standard Deviation 1.27655833
|
-0.306720406 changes in BOLD responses
Standard Deviation 1.245533541
|
-0.214274187 changes in BOLD responses
Standard Deviation 1.6338638
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase
|
0.130227 change in BOLD responses
Standard Deviation 1.372415
|
0.296665 change in BOLD responses
Standard Deviation 1.181538
|
0.295264 change in BOLD responses
Standard Deviation 1.16357
|
0.605202 change in BOLD responses
Standard Deviation 1.608406
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Reinstatement Phase
|
0.057116 change in BOLD responses
Standard Deviation 1.260536
|
0.447198 change in BOLD responses
Standard Deviation 1.340947
|
0.151774 change in BOLD responses
Standard Deviation 1.466662
|
0.66191 change in BOLD responses
Standard Deviation 1.598863
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Reinstatement Phase
|
-0.11068 change in BOLD responses
Standard Deviation 1.31177
|
-0.03876 change in BOLD responses
Standard Deviation 1.292054
|
0.145557 change in BOLD responses
Standard Deviation 1.243421
|
-0.06121 change in BOLD responses
Standard Deviation 1.285574
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Amygdala During the Reinstatement Phase
|
-0.14044 change in BOLD responses
Standard Deviation 1.142882
|
0.213951 change in BOLD responses
Standard Deviation 1.122094
|
0.114811 change in BOLD responses
Standard Deviation 1.414787
|
0.15224 change in BOLD responses
Standard Deviation 1.207956
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugmean skin conductance responses (SCR) for CS- stimuli during Extinction
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Skin Conductance Responses (SCR) to CS- During Extinction
|
0.02 microsiemens
Standard Deviation 0.02
|
0.03 microsiemens
Standard Deviation 0.03
|
0.04 microsiemens
Standard Deviation 0.06
|
0.02 microsiemens
Standard Deviation 0.01
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugmean skin conductance responses (SCR) for CS+S stimuli during Extinction
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Skin Conductance Responses (SCR) to CS+S During Extinction
|
0.03 microsiemens
Standard Deviation 0.02
|
0.03 microsiemens
Standard Deviation 0.02
|
0.05 microsiemens
Standard Deviation 0.01
|
0.02 microsiemens
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugmean skin conductance responses (SCR) for CS+R stimuli during Extinction
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Skin Conductance Responses (SCR) to CS+R During Extinction
|
0.03 microsiemens
Standard Deviation 0.03
|
0.03 microsiemens
Standard Deviation 0.04
|
0.04 microsiemens
Standard Deviation 0.07
|
0.02 microsiemens
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugmean skin conductance responses (SCR) for CS- stimuli during Reinstatement
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Skin Conductance Responses (SCR) to CS- During Reinstatement
|
0.03 microsiemens
Standard Deviation 0.04
|
0.04 microsiemens
Standard Deviation 0.07
|
0.04 microsiemens
Standard Deviation 0.07
|
0.05 microsiemens
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugmean skin conductance responses (SCR) for CS+S stimuli during Reinstatement
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Skin Conductance Responses (SCR) to CS+S During Reinstatement
|
0.06 microsiemens
Standard Deviation 0.06
|
0.08 microsiemens
Standard Deviation 0.12
|
0.07 microsiemens
Standard Deviation 0.01
|
0.07 microsiemens
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugmean skin conductance responses (SCR) for CS+R stimuli during Reinstatement
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Skin Conductance Responses (SCR) to CS+R During Reinstatement
|
0.10 microsiemens
Standard Deviation 0.14
|
0.09 microsiemens
Standard Deviation 0.11
|
0.08 microsiemens
Standard Deviation 0.12
|
0.08 microsiemens
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS- Contrast in the Insula During the Extinction Phase
|
-0.048053691 change in BOLD responses
Standard Deviation 1.36899941
|
0.264588537 change in BOLD responses
Standard Deviation 1.577661458
|
0.279971677 change in BOLD responses
Standard Deviation 1.21795838
|
0.708900671 change in BOLD responses
Standard Deviation 1.49947924
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS- Contrast in the Amygdala During the Extinction Phase
|
-0.08101320 change in BOLD responses
Standard Deviation 0.7983
|
-0.327437765 change in BOLD responses
Standard Deviation 0.931213858
|
-0.023351832 change in BOLD responses
Standard Deviation 1.40505956
|
-0.490350729 change in BOLD responses
Standard Deviation 1.360381133
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
|
-0.36278 change in BOLD responses
Standard Deviation 1.330302
|
0.043883 change in BOLD responses
Standard Deviation 1.046009
|
0.222867 change in BOLD responses
Standard Deviation 1.302505
|
0.299902 change in BOLD responses
Standard Deviation 1.268789
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS- Contrast in the Hippocampus During the Extinction Phase
|
-0.559612442 change in BOLD responses
Standard Deviation 1.532436298
|
-0.746694474 change in BOLD responses
Standard Deviation 1.040686673
|
-0.344025135 change in BOLD responses
Standard Deviation 1.510782312
|
-0.978229125 change in BOLD responses
Standard Deviation 1.717965709
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS- Contrast in the Anterior Cingulate Cortex During the Extinction Phase
|
-0.147310521 change in BOLD responses
Standard Deviation 1.240041128
|
0.506042926 change in BOLD responses
Standard Deviation 1.618323353
|
0.423485753 change in BOLD responses
Standard Deviation 1.259903072
|
0.770724864 change in BOLD responses
Standard Deviation 1.419967213
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase
|
-0.40540628 change in BOLD responses
Standard Deviation 1.362599688
|
-0.120150283 change in BOLD responses
Standard Deviation 1.240041128
|
-0.393528327 change in BOLD responses
Standard Deviation 1.27006626
|
-0.385634084 change in BOLD responses
Standard Deviation 1.665910989
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS- Contrast in the Amygdala During the Reinstatement Phase
|
-0.412378445 change in BOLD responses
Standard Deviation 1.386140637
|
-0.00869704 change in BOLD responses
Standard Deviation 1.048446472
|
-0.295224068 change in BOLD responses
Standard Deviation 1.446046052
|
-0.303311941 change in BOLD responses
Standard Deviation 1.532289751
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS- Contrast in the Insula During the Reinstatement Phase
|
0.053789723 change in BOLD responses
Standard Deviation 1.269563744
|
0.033436733 change in BOLD responses
Standard Deviation 1.221067419
|
-0.037957909 change in BOLD responses
Standard Deviation 1.38667917
|
0.461845841 change in BOLD responses
Standard Deviation 1.793083911
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS- Contrast in the Hippocampus During the Reinstatement Phase
|
-0.516644315 change in BOLD responses
Standard Deviation 1.550951364
|
-0.676128825 change in BOLD responses
Standard Deviation 1.133257628
|
-0.668993539 change in BOLD responses
Standard Deviation 1.329069179
|
-0.405800121 change in BOLD responses
Standard Deviation 1.444904163
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS- Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase
|
0.36891754 change in BOLD responses
Standard Deviation 1.440178669
|
-0.052933723 change in BOLD responses
Standard Deviation 1.257636002
|
0.310523262 change in BOLD responses
Standard Deviation 1.419753
|
0.610406015 change in BOLD responses
Standard Deviation 1.60736525
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during vicarious extinction (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+S vs CS- Contrast in the Hippocampus During the Extinction Phase
|
0.036121 change in BOLD responses
Standard Deviation 1.195781
|
-0.26162 change in BOLD responses
Standard Deviation 1.103313
|
-0.13658 change in BOLD responses
Standard Deviation 1.510163
|
-0.12299 change in BOLD responses
Standard Deviation 1.02176
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
|
-0.187647034 change in BOLD responses
Standard Deviation 1.439881626
|
-0.454606143 change in BOLD responses
Standard Deviation 1.488956065
|
-0.20235762 change in BOLD responses
Standard Deviation 1.136844267
|
-0.534531006 change in BOLD responses
Standard Deviation 1.222443652
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during vicarious extinction (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+S vs CS- Contrast in the Amygdala During the Extinction Phase
|
0.427054 change in BOLD responses
Standard Deviation 0.897206
|
-0.04668 change in BOLD responses
Standard Deviation 1.038413
|
0.123645 change in BOLD responses
Standard Deviation 1.434702
|
-0.15423 change in BOLD responses
Standard Deviation 0.813785
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during vicarious extinction (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+S vs CS- Contrast in the Insula During the Extinction Phase
|
0.286 change in BOLD responses
Standard Deviation 1.52798
|
-0.06139 change in BOLD responses
Standard Deviation 1.193319
|
0.41607 change in BOLD responses
Standard Deviation 1.368194
|
0.521877 change in BOLD responses
Standard Deviation 1.628942
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during vicarious extinction (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+S vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase
|
-0.18984 change in BOLD responses
Standard Deviation 1.50548
|
-0.2251 change in BOLD responses
Standard Deviation 1.234075
|
-0.06763 change in BOLD responses
Standard Deviation 1.456314
|
-0.13561 change in BOLD responses
Standard Deviation 1.157759
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during vicarious extinction (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+S vs CS- Contrast in the Anterior Cingulate Cortex During the Extinction Phase
|
-0.06847 change in BOLD responses
Standard Deviation 1.290338
|
0.426162 change in BOLD responses
Standard Deviation 1.254211
|
0.248436 change in BOLD responses
Standard Deviation 1.286357
|
0.45761 change in BOLD responses
Standard Deviation 1.544828
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+S vs CS- Contrast in the Amygdala During the Reinstatement Phase
|
-0.288669878 change in BOLD responses
Standard Deviation 1.083123573
|
-0.210806049 change in BOLD responses
Standard Deviation 1.156940846
|
-0.384666972 change in BOLD responses
Standard Deviation 1.408336943
|
-0.441281889 change in BOLD responses
Standard Deviation 1.423147097
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+S vs CS- Contrast in the Insula During the Reinstatement Phase
|
-0.010511119 change in BOLD responses
Standard Deviation 0.927239751
|
-0.396205137 change in BOLD responses
Standard Deviation 1.282513188
|
-0.172611047 change in BOLD responses
Standard Deviation 1.456173074
|
-0.151751057 change in BOLD responses
Standard Deviation 1.284854554
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+S vs CS- Contrast in the Hippocampus During the Reinstatement Phase
|
-0.414195593 change in BOLD responses
Standard Deviation 1.11038608
|
-0.62547086 change in BOLD responses
Standard Deviation 1.105693682
|
-0.779153039 change in BOLD responses
Standard Deviation 1.230802297
|
-0.348783805 change in BOLD responses
Standard Deviation 1.556676926
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+S vs CS- Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase
|
0.227684066 change in BOLD responses
Standard Deviation 1.292814465
|
-0.325810809 change in BOLD responses
Standard Deviation 1.37744721
|
0.034259204 change in BOLD responses
Standard Deviation 1.627607411
|
0.045481876 change in BOLD responses
Standard Deviation 0.86287483
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+S vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
|
0.153279119 change in BOLD responses
Standard Deviation 0.823471745
|
-0.473945639 change in BOLD responses
Standard Deviation 1.508637505
|
-0.40188084 change in BOLD responses
Standard Deviation 1.336276781
|
-0.823944573 change in BOLD responses
Standard Deviation 0.980841852
|
PRIMARY outcome
Timeframe: immediately (45 minutes) after receiving drugPopulation: One healthy control participant who was allocated to the placebo group decided they no longer wanted to participate in fMRI scan.
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions). Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model. Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
Outcome measures
| Measure |
Clinical-Placebo
n=23 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 Participants
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization).
|
Controls-Placebo
n=28 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 Participants
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
|
-0.36278 change in BOLD signal
Standard Deviation 1.330302
|
0.043883 change in BOLD signal
Standard Deviation 1.046009
|
0.222867 change in BOLD signal
Standard Deviation 1.302505
|
0.299902 change in BOLD signal
Standard Deviation 1.268789
|
Adverse Events
Clinical-Placebo
Clinical-Oxytocin
Controls-Placebo
Controls-Oxytocin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clinical-Placebo
n=23 participants at risk
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive a placebo administration (assigned via blind randomization).
|
Clinical-Oxytocin
n=28 participants at risk
This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive an oxytocin administration (assigned via blind randomization)
|
Controls-Placebo
n=28 participants at risk
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive a placebo administration (assigned via blind randomization).
|
Controls-Oxytocin
n=24 participants at risk
This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive an oxytocin administration (assigned via blind randomization).
|
|---|---|---|---|---|
|
Nervous system disorders
Lightheaded, Headache, Tired, Drowsy, Sleepy
|
4.3%
1/23 • From drug administration through the end of the experimental session, an average of 2 hours
|
10.7%
3/28 • From drug administration through the end of the experimental session, an average of 2 hours
|
10.7%
3/28 • From drug administration through the end of the experimental session, an average of 2 hours
|
12.5%
3/24 • From drug administration through the end of the experimental session, an average of 2 hours
|
|
Psychiatric disorders
Irritability
|
0.00%
0/23 • From drug administration through the end of the experimental session, an average of 2 hours
|
3.6%
1/28 • From drug administration through the end of the experimental session, an average of 2 hours
|
3.6%
1/28 • From drug administration through the end of the experimental session, an average of 2 hours
|
0.00%
0/24 • From drug administration through the end of the experimental session, an average of 2 hours
|
|
Respiratory, thoracic and mediastinal disorders
Nasal irritation/discomfort, Runny Nose, Irritation in throat, Dry throat and mouth
|
47.8%
11/23 • From drug administration through the end of the experimental session, an average of 2 hours
|
50.0%
14/28 • From drug administration through the end of the experimental session, an average of 2 hours
|
53.6%
15/28 • From drug administration through the end of the experimental session, an average of 2 hours
|
45.8%
11/24 • From drug administration through the end of the experimental session, an average of 2 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place