Trial Outcomes & Findings for Inhaled Oxytocin and HPA Axis Reactivity (NCT NCT03593473)
NCT ID: NCT03593473
Last Updated: 2025-08-08
Results Overview
The study drug will be administered 40 minutes before the TSST. Serum cortisol will be measured via peripheral IV 40 (-40) and 20 (-20) minutes before the TSST, at the start of the TSST (0 minutes), and at minutes 10 (during the speech task), 15 (during the math task), 28, 38, and 48 (during recovery).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
-40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes
Results posted on
2025-08-08
Participant Flow
Participant milestones
| Measure |
Intranasal Oxytocin
Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Intranasal Oxytocin: Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.
|
Placebo
Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Placebo: Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
56
|
|
Overall Study
Randomized
|
53
|
56
|
|
Overall Study
Received Intervention
|
51
|
54
|
|
Overall Study
COMPLETED
|
51
|
54
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhaled Oxytocin and HPA Axis Reactivity
Baseline characteristics by cohort
| Measure |
Intranasal Oxytocin
n=51 Participants
Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Intranasal Oxytocin: Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.
|
Placebo
n=54 Participants
Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Placebo: Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.63 years
STANDARD_DEVIATION 4.38 • n=99 Participants
|
38.26 years
STANDARD_DEVIATION 3.98 • n=107 Participants
|
37.95 years
STANDARD_DEVIATION 4.17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutesPopulation: Samples were collected by IV. In some participants, an IV was not able to be placed and samples could not be collected. In some participants, an IV was successfully placed, but the IV infiltrated before the end of the observation period and not all timepoints were collected. One participant had a vasovagal episode when the IV was placed and samples were not collected. All collected data are reported herein.
The study drug will be administered 40 minutes before the TSST. Serum cortisol will be measured via peripheral IV 40 (-40) and 20 (-20) minutes before the TSST, at the start of the TSST (0 minutes), and at minutes 10 (during the speech task), 15 (during the math task), 28, 38, and 48 (during recovery).
Outcome measures
| Measure |
Intranasal Oxytocin
n=42 Participants
Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Intranasal Oxytocin: Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.
|
Placebo
n=47 Participants
Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Placebo: Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.
|
|---|---|---|
|
Mean Cortisol (CRT) During Trier Social Stress Test (TSST)
-40 minutes
|
19.17 pg/mL
Standard Deviation 13.46
|
16.87 pg/mL
Standard Deviation 10.84
|
|
Mean Cortisol (CRT) During Trier Social Stress Test (TSST)
-20 minutes
|
15.71 pg/mL
Standard Deviation 10.16
|
13.89 pg/mL
Standard Deviation 9.68
|
|
Mean Cortisol (CRT) During Trier Social Stress Test (TSST)
0 minutes
|
14.06 pg/mL
Standard Deviation 10.41
|
13.03 pg/mL
Standard Deviation 8.99
|
|
Mean Cortisol (CRT) During Trier Social Stress Test (TSST)
+10 minutes
|
14.39 pg/mL
Standard Deviation 10.55
|
13.60 pg/mL
Standard Deviation 9.45
|
|
Mean Cortisol (CRT) During Trier Social Stress Test (TSST)
+15 minutes
|
15.27 pg/mL
Standard Deviation 12.56
|
15.64 pg/mL
Standard Deviation 10.16
|
|
Mean Cortisol (CRT) During Trier Social Stress Test (TSST)
+28 minutes
|
16.78 pg/mL
Standard Deviation 13.63
|
16.29 pg/mL
Standard Deviation 9.44
|
|
Mean Cortisol (CRT) During Trier Social Stress Test (TSST)
+38 minutes
|
14.50 pg/mL
Standard Deviation 12.02
|
15.40 pg/mL
Standard Deviation 9.66
|
|
Mean Cortisol (CRT) During Trier Social Stress Test (TSST)
+48 minutes
|
13.16 pg/mL
Standard Deviation 9.35
|
14.41 pg/mL
Standard Deviation 9.02
|
SECONDARY outcome
Timeframe: -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutesPopulation: Samples were collected by IV. In some participants, an IV was not able to be placed and samples could not be collected. In some participants, an IV was successfully placed, but the IV infiltrated before the end of the observation period and not all timepoints were collected. One participant had a vasovagal episode when the IV was placed and samples were not collected. All collected data are reported herein.
The study drug will be administered 40 minutes before the TSST. Adrenocorticotropic hormone will be measured via peripheral IV 40 (-40) and 20 (-20) minutes before the TSST, at the start of the TSST (0 minutes), and at minutes 10 (during the speech task), 15 (during the math task), 28, 38, and 48 (during recovery).
Outcome measures
| Measure |
Intranasal Oxytocin
n=42 Participants
Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Intranasal Oxytocin: Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.
|
Placebo
n=47 Participants
Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Placebo: Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.
|
|---|---|---|
|
Mean Adrenocorticotropic Hormone (ACTH ) During TSST
-40 minutes
|
79.96 pg/mL
Standard Deviation 64.89
|
86.77 pg/mL
Standard Deviation 103.00
|
|
Mean Adrenocorticotropic Hormone (ACTH ) During TSST
-20 minutes
|
85.73 pg/mL
Standard Deviation 68.28
|
87.61 pg/mL
Standard Deviation 92.74
|
|
Mean Adrenocorticotropic Hormone (ACTH ) During TSST
0 minutes
|
84.31 pg/mL
Standard Deviation 54.49
|
86.10 pg/mL
Standard Deviation 93.42
|
|
Mean Adrenocorticotropic Hormone (ACTH ) During TSST
+10 minutes
|
80.31 pg/mL
Standard Deviation 59.49
|
94.00 pg/mL
Standard Deviation 86.89
|
|
Mean Adrenocorticotropic Hormone (ACTH ) During TSST
+15 minutes
|
93.46 pg/mL
Standard Deviation 59.92
|
94.21 pg/mL
Standard Deviation 104.00
|
|
Mean Adrenocorticotropic Hormone (ACTH ) During TSST
+28 minutes
|
84.02 pg/mL
Standard Deviation 64.26
|
77.48 pg/mL
Standard Deviation 87.08
|
|
Mean Adrenocorticotropic Hormone (ACTH ) During TSST
+38 minutes
|
79.38 pg/mL
Standard Deviation 63.01
|
84.01 pg/mL
Standard Deviation 81.48
|
|
Mean Adrenocorticotropic Hormone (ACTH ) During TSST
+48 minutes
|
77.27 pg/mL
Standard Deviation 63.69
|
85.30 pg/mL
Standard Deviation 74.79
|
SECONDARY outcome
Timeframe: ACTH at -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes and Cortisol at -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutesPopulation: Samples were collected by IV. In some participants, an IV was not able to be placed and samples could not be collected. In some participants, an IV was successfully placed, but the IV infiltrated before the end of the observation period and not all timepoints were collected. One participant had a vasovagal episode when the IV was placed and samples were not collected. All collected data are reported herein.
Correlations will be quantified between ACTH at time j and CRT at time j+1 to test the extent to which CRT response is blunted by exogenous oxytocin (OT).
Outcome measures
| Measure |
Intranasal Oxytocin
n=41 Participants
Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Intranasal Oxytocin: Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.
|
Placebo
n=44 Participants
Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Placebo: Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.
|
|---|---|---|
|
Lagged Association Between ACTH and CRT During the TSST
ACTH at -40 minutes with Cortisol at -20 minutes
|
0.07 Correlation coefficient
|
0.44 Correlation coefficient
|
|
Lagged Association Between ACTH and CRT During the TSST
ACTH at -20 minutes with 0 minutes
|
0.04 Correlation coefficient
|
0.31 Correlation coefficient
|
|
Lagged Association Between ACTH and CRT During the TSST
ACTH at 0 minutes with Cortisol at +10 minutes
|
0.16 Correlation coefficient
|
0.46 Correlation coefficient
|
|
Lagged Association Between ACTH and CRT During the TSST
ACTH at +10 minutes with Cortisol at +15 minutes
|
0.01 Correlation coefficient
|
0.34 Correlation coefficient
|
|
Lagged Association Between ACTH and CRT During the TSST
ACTH at +15 minutes with Cortisol at +28 minutes
|
-0.04 Correlation coefficient
|
0.40 Correlation coefficient
|
|
Lagged Association Between ACTH and CRT During the TSST
ACTH at +28 minutes with Cortisol at +38 minutes
|
0.10 Correlation coefficient
|
0.47 Correlation coefficient
|
|
Lagged Association Between ACTH and CRT During the TSST
ACTH at +38 minutes with Cortisol at +48 minutes
|
0.29 Correlation coefficient
|
0.26 Correlation coefficient
|
SECONDARY outcome
Timeframe: Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48Population: For two participants in each arm, cardiograph recording was unsuccessful. For some time periods for some participants, data quality or quantity (in terms of lacking sufficient numbers of epochs within a period) was insufficient for analysis. All valid, analyzable data are reported herein.
Recording of autonomic activity beginning prior to study drug administration (-40 minutes) until the end of recovery from the TSST (+38 minutes). Mobile Impedance Cardiographs (MindWare Tech Ltd, Gahanna, OH) was used to measure cardiac rate and interbeat interval (IBI). MindWare Heart Rate Variability (HRV) software was used to derive respiration and to calculate high frequency respiratory sinus arrhythmia power from the IBI series as an index of parasympathetic activity. Results are reported as difference from the mean of high frequency respiratory sinus arrhythmia power measured in the first ten minutes of the study visit, prior to administration of OT or placebo.
Outcome measures
| Measure |
Intranasal Oxytocin
n=49 Participants
Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Intranasal Oxytocin: Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.
|
Placebo
n=52 Participants
Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Placebo: Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.
|
|---|---|---|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
-40 to -35
|
9.4867 ms squared
Standard Deviation 367.6
|
25.2298 ms squared
Standard Deviation 426.2
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
-35 to -30
|
-54.8211 ms squared
Standard Deviation 341
|
-76.7692 ms squared
Standard Deviation 476.9
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
-30 to -25
|
25.9791 ms squared
Standard Deviation 520.3
|
-34.2107 ms squared
Standard Deviation 513.2
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
-25 to -20
|
8.1879 ms squared
Standard Deviation 412.4
|
-85.2953 ms squared
Standard Deviation 494
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
-20 to -15
|
29.8191 ms squared
Standard Deviation 355.4
|
-34.1119 ms squared
Standard Deviation 427.6
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
-15 to -10
|
-65.0835 ms squared
Standard Deviation 303.9
|
-50.8918 ms squared
Standard Deviation 363
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
-10 to -5
|
-40.6283 ms squared
Standard Deviation 291
|
-65.8414 ms squared
Standard Deviation 487.4
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
-5 to 0
|
-66.7889 ms squared
Standard Deviation 365.5
|
-0.2369 ms squared
Standard Deviation 440.3
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
5 to 8
|
-213.8 ms squared
Standard Deviation 577.3
|
-60.7299 ms squared
Standard Deviation 424.1
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
8 to 13
|
-142.7 ms squared
Standard Deviation 729.6
|
-93.6755 ms squared
Standard Deviation 585.2
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
13 to 18
|
-166 ms squared
Standard Deviation 702.4
|
45.2548 ms squared
Standard Deviation 701.9
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
18 to 23
|
-54.7814 ms squared
Standard Deviation 538.4
|
140.5 ms squared
Standard Deviation 416
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
23 to 28
|
-55.4212 ms squared
Standard Deviation 376.5
|
90.0612 ms squared
Standard Deviation 574.9
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
28 to 33
|
-2.1457 ms squared
Standard Deviation 484.3
|
78.347 ms squared
Standard Deviation 480
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
33 to 38
|
10.4342 ms squared
Standard Deviation 551.7
|
94.173 ms squared
Standard Deviation 439.2
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
38 to 43
|
-31.2704 ms squared
Standard Deviation 497
|
74.8732 ms squared
Standard Deviation 390.8
|
|
Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST
43 to 48
|
-66.8297 ms squared
Standard Deviation 498.9
|
82.3593 ms squared
Standard Deviation 289.3
|
SECONDARY outcome
Timeframe: Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48Population: For some participants in each arm, cardiograph recording was unsuccessful. For some time periods for some participants, data quality or quantity (in terms of lacking sufficient numbers of epochs within a period) was insufficient for analysis. All valid, analyzable data are reported herein.
Recording of autonomic activity beginning prior to study drug administration (-40 minutes) until the end of recovery from the TSST (+38 minutes). Mobile Impedance Cardiographs (MindWare Tech Ltd, Gahanna, OH) will be used to measure pre-ejection period (PEP). PEP will index sympathetic activation. Results are reported as difference from the mean of pre-ejection period measured in the first ten minutes of the study visit, prior to administration of OT or placebo.
Outcome measures
| Measure |
Intranasal Oxytocin
n=46 Participants
Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Intranasal Oxytocin: Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.
|
Placebo
n=39 Participants
Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Placebo: Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.
|
|---|---|---|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
-40 to -35
|
-0.0133 milliseconds
Standard Deviation 5.0895
|
-0.5344 milliseconds
Standard Deviation 5.2068
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
-35 to -30
|
-0.4379 milliseconds
Standard Deviation 4.6949
|
-1.578 milliseconds
Standard Deviation 5.6245
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
-30 to -25
|
-0.0765 milliseconds
Standard Deviation 4.8828
|
-1.2421 milliseconds
Standard Deviation 6.3071
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
-25 to -20
|
0.1364 milliseconds
Standard Deviation 5.4471
|
-0.9139 milliseconds
Standard Deviation 6.4616
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
-20 to -15
|
0.4913 milliseconds
Standard Deviation 6.0127
|
-0.743 milliseconds
Standard Deviation 5.4354
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
-15 to -10
|
0.396 milliseconds
Standard Deviation 6.5937
|
-1.2658 milliseconds
Standard Deviation 6.5275
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
-10 to -5
|
0.1857 milliseconds
Standard Deviation 5.745
|
-1.9649 milliseconds
Standard Deviation 6.0961
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
-5 to 0
|
0.7484 milliseconds
Standard Deviation 5.8793
|
-2.3991 milliseconds
Standard Deviation 5.8181
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
5 to 8
|
-4.9659 milliseconds
Standard Deviation 7.7046
|
-6.9426 milliseconds
Standard Deviation 14.7706
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
8 to 13
|
-4.9797 milliseconds
Standard Deviation 14.7581
|
-6.7011 milliseconds
Standard Deviation 12.5175
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
13 to 18
|
-4.4699 milliseconds
Standard Deviation 14.2813
|
-7.2932 milliseconds
Standard Deviation 12.2579
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
18 to 23
|
0.3473 milliseconds
Standard Deviation 6.8964
|
-1.7225 milliseconds
Standard Deviation 5.6289
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
23 to 28
|
1.0633 milliseconds
Standard Deviation 5.9026
|
-0.5384 milliseconds
Standard Deviation 5.2814
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
28 to 33
|
1.47 milliseconds
Standard Deviation 5.9291
|
-0.3492 milliseconds
Standard Deviation 4.7881
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
33 to 38
|
1.1908 milliseconds
Standard Deviation 5.6515
|
-0.706 milliseconds
Standard Deviation 4.7005
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
38 to 43
|
1.3179 milliseconds
Standard Deviation 5.8975
|
-0.3979 milliseconds
Standard Deviation 4.7213
|
|
Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST
43 to 48
|
1.2028 milliseconds
Standard Deviation 5.8875
|
-0.833 milliseconds
Standard Deviation 4.2802
|
OTHER_PRE_SPECIFIED outcome
Timeframe: -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutesStratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on CRT during the TSST.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutesStratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on ACTH during the TSST.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on parasympathetic activity during the TSST.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on sympathetic activity during the TSST.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutesStratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on CRT during the TSST.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: -30 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutesStratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on ACTH during the TSST.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on parasympathetic activity during the TSST.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on sympathetic activity during the TSST.
Outcome measures
Outcome data not reported
Adverse Events
Intranasal Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Oxytocin
n=51 participants at risk
Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Intranasal Oxytocin: Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.
|
Placebo
n=54 participants at risk
Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).
Placebo: Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.
|
|---|---|---|
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General disorders
Hypotension
|
0.00%
0/51 • From the time of study drug administration through the end of the recovery period, a total of approximately 90 minutes.
|
1.9%
1/54 • Number of events 1 • From the time of study drug administration through the end of the recovery period, a total of approximately 90 minutes.
|
Additional Information
Alison Stuebe, MD, MSc
University of North Carollina at Chapel Hill
Phone: 919-966-1601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place