Trial Outcomes & Findings for The Effects of Dopamine on Reward Processing (NCT NCT01253421)

NCT ID: NCT01253421

Last Updated: 2018-04-27

Results Overview

This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from rewards during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from reward trials.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

159 participants

Primary outcome timeframe

administered after scan

Results posted on

2018-04-27

Participant Flow

Participants were recruited at McLean Hospital (Belmont, MA) and Massachusetts General Hospital (MGH; Boston, MA) between February, 2012, and September, 2015. The study was advertised using flyers, and on a number of internet bulletin boards available to the general public. Study visits were conducted in research facilities at McLean Hospital.

An assessment visit was conducted prior to the drug-challenge visit. Subjects had a diagnostic interview (SCID) and preliminary physical exam, provided a blood sample for lab tests, and completed surveys, to determine eligibility. Those meeting eligibility criteria were scheduled for a drug+scanning visit where randomization occurred.

Participant milestones

Participant milestones
Measure
All Participants Prior to Randomization
All Participants went through Assessment, prior to randomization.
MDD-amisulpride
Subjects experiencing a current episode of major depression who are randomized to receive amisulpride
MDD-placebo
Subjects experiencing a current episode of major depression who are randomized to receive placebo
HC-amisulpride
Subjects having no history of mental disorder who are randomized to receive amisulpride
HC-placebo
Subjects having no history of mental disorder who are randomized to receive placebo
Assessment and Scheduling
STARTED
159
0
0
0
0
Assessment and Scheduling
Eligible After Screening Visit
85
0
0
0
0
Assessment and Scheduling
Returned for Drug+Scanning Visit
60
0
0
0
0
Assessment and Scheduling
COMPLETED
60
0
0
0
0
Assessment and Scheduling
NOT COMPLETED
99
0
0
0
0
Drug+Scanning Visit
STARTED
0
15
14
16
15
Drug+Scanning Visit
Received Drug Challenge
0
15
14
16
15
Drug+Scanning Visit
COMPLETED
0
15
14
16
14
Drug+Scanning Visit
NOT COMPLETED
0
0
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
All Participants Prior to Randomization
All Participants went through Assessment, prior to randomization.
MDD-amisulpride
Subjects experiencing a current episode of major depression who are randomized to receive amisulpride
MDD-placebo
Subjects experiencing a current episode of major depression who are randomized to receive placebo
HC-amisulpride
Subjects having no history of mental disorder who are randomized to receive amisulpride
HC-placebo
Subjects having no history of mental disorder who are randomized to receive placebo
Assessment and Scheduling
Found to be Ineligible
74
0
0
0
0
Assessment and Scheduling
Lost to Follow-up
17
0
0
0
0
Assessment and Scheduling
Withdrawal by Subject
7
0
0
0
0
Assessment and Scheduling
Physician Decision
1
0
0
0
0
Drug+Scanning Visit
Physician Decision
0
0
0
0
1

Baseline Characteristics

Percent among females only

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MDD-amisulpride
n=15 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=14 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=16 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=14 Participants
Subjects having no history of mental disorder who received placebo
Total
n=59 Participants
Total of all reporting groups
Age, Continuous
27.20 years
STANDARD_DEVIATION 8.6 • n=15 Participants
25.8 years
STANDARD_DEVIATION 5.35 • n=14 Participants
25.3 years
STANDARD_DEVIATION 25.3 • n=16 Participants
24.7 years
STANDARD_DEVIATION 24.7 • n=14 Participants
26 years
STANDARD_DEVIATION 6.79 • n=59 Participants
Sex: Female, Male
Female
12 Participants
n=15 Participants
6 Participants
n=14 Participants
11 Participants
n=16 Participants
9 Participants
n=14 Participants
38 Participants
n=59 Participants
Sex: Female, Male
Male
3 Participants
n=15 Participants
8 Participants
n=14 Participants
5 Participants
n=16 Participants
5 Participants
n=14 Participants
21 Participants
n=59 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=15 Participants
1 Participants
n=14 Participants
3 Participants
n=16 Participants
0 Participants
n=14 Participants
7 Participants
n=59 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=15 Participants
13 Participants
n=14 Participants
12 Participants
n=16 Participants
14 Participants
n=14 Participants
51 Participants
n=59 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=15 Participants
0 Participants
n=14 Participants
1 Participants
n=16 Participants
0 Participants
n=14 Participants
1 Participants
n=59 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=15 Participants
0 Participants
n=14 Participants
1 Participants
n=16 Participants
0 Participants
n=14 Participants
1 Participants
n=59 Participants
Race (NIH/OMB)
Asian
2 Participants
n=15 Participants
2 Participants
n=14 Participants
0 Participants
n=16 Participants
5 Participants
n=14 Participants
9 Participants
n=59 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=15 Participants
0 Participants
n=14 Participants
0 Participants
n=16 Participants
0 Participants
n=14 Participants
0 Participants
n=59 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=15 Participants
2 Participants
n=14 Participants
3 Participants
n=16 Participants
3 Participants
n=14 Participants
9 Participants
n=59 Participants
Race (NIH/OMB)
White
11 Participants
n=15 Participants
9 Participants
n=14 Participants
10 Participants
n=16 Participants
6 Participants
n=14 Participants
36 Participants
n=59 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=15 Participants
1 Participants
n=14 Participants
1 Participants
n=16 Participants
0 Participants
n=14 Participants
3 Participants
n=59 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=15 Participants
0 Participants
n=14 Participants
1 Participants
n=16 Participants
0 Participants
n=14 Participants
1 Participants
n=59 Participants
Region of Enrollment
United States
15 Participants
n=15 Participants
14 Participants
n=14 Participants
16 Participants
n=16 Participants
14 Participants
n=14 Participants
59 Participants
n=59 Participants
Educ-yrs
15.6 years
STANDARD_DEVIATION 2.06 • n=15 Participants
16.6 years
STANDARD_DEVIATION 2.90 • n=14 Participants
16.2 years
STANDARD_DEVIATION 2.13 • n=16 Participants
16.5 years
STANDARD_DEVIATION 1.52 • n=14 Participants
16.2 years
STANDARD_DEVIATION 2.18 • n=59 Participants
Menstrual phase
Follicular
1 Participants
n=12 Participants • Percent among females only
2 Participants
n=6 Participants • Percent among females only
6 Participants
n=11 Participants • Percent among females only
3 Participants
n=9 Participants • Percent among females only
12 Participants
n=38 Participants • Percent among females only
Menstrual phase
Luteal
4 Participants
n=12 Participants • Percent among females only
1 Participants
n=6 Participants • Percent among females only
1 Participants
n=11 Participants • Percent among females only
3 Participants
n=9 Participants • Percent among females only
9 Participants
n=38 Participants • Percent among females only
Menstrual phase
Unknown
7 Participants
n=12 Participants • Percent among females only
3 Participants
n=6 Participants • Percent among females only
4 Participants
n=11 Participants • Percent among females only
3 Participants
n=9 Participants • Percent among females only
17 Participants
n=38 Participants • Percent among females only
HRSD
16.4 units on a scale
STANDARD_DEVIATION 3.37 • n=14 Participants • 5 missing values
18.4 units on a scale
STANDARD_DEVIATION 5.09 • n=14 Participants • 5 missing values
1.0 units on a scale
STANDARD_DEVIATION 1.58 • n=13 Participants • 5 missing values
0.5 units on a scale
STANDARD_DEVIATION 0.66 • n=13 Participants • 5 missing values
9.37 units on a scale
STANDARD_DEVIATION 8.997 • n=54 Participants • 5 missing values
MDD SCID rating
2.9 units on a scale
STANDARD_DEVIATION .27 • n=15 Participants
2.9 units on a scale
STANDARD_DEVIATION .27 • n=14 Participants
1 units on a scale
STANDARD_DEVIATION 0 • n=16 Participants
1 units on a scale
STANDARD_DEVIATION 0 • n=14 Participants
1.93 units on a scale
STANDARD_DEVIATION .99 • n=59 Participants
# MDEs
2.75 Episodes
STANDARD_DEVIATION 2.667 • n=15 Participants • Applies to MDD subjects only
4.79 Episodes
STANDARD_DEVIATION 3.490 • n=14 Participants • Applies to MDD subjects only
3.74 Episodes
STANDARD_DEVIATION 3.230 • n=29 Participants • Applies to MDD subjects only
Length_MDE
20.50 months
STANDARD_DEVIATION 16.53 • n=15 Participants • Statistics include MDD subjects only
14.00 months
STANDARD_DEVIATION 18.982 • n=14 Participants • Statistics include MDD subjects only
16.17 months
STANDARD_DEVIATION 17.771 • n=29 Participants • Statistics include MDD subjects only
Patients with comorbid anxiety disorder
Has comorbid Anxiety Disorder
3 Participants
n=15 Participants
6 Participants
n=14 Participants
0 Participants
n=16 Participants
0 Participants
n=14 Participants
9 Participants
n=59 Participants
Patients with comorbid anxiety disorder
No comorbid Anxiety Disorder
9 Participants
n=15 Participants
8 Participants
n=14 Participants
16 Participants
n=16 Participants
14 Participants
n=14 Participants
47 Participants
n=59 Participants
Patients with comorbid anxiety disorder
Unknown
3 Participants
n=15 Participants
0 Participants
n=14 Participants
0 Participants
n=16 Participants
0 Participants
n=14 Participants
3 Participants
n=59 Participants
Patients with past anxiety disorder
Yes
3 Participants
n=15 Participants
6 Participants
n=14 Participants
0 Participants
n=16 Participants
0 Participants
n=14 Participants
9 Participants
n=59 Participants
Patients with past anxiety disorder
No
9 Participants
n=15 Participants
8 Participants
n=14 Participants
16 Participants
n=16 Participants
14 Participants
n=14 Participants
47 Participants
n=59 Participants
Patients with past anxiety disorder
Unknown
3 Participants
n=15 Participants
0 Participants
n=14 Participants
0 Participants
n=16 Participants
0 Participants
n=14 Participants
3 Participants
n=59 Participants
TCI Total
87.97 units on a scale
STANDARD_DEVIATION 13.992 • n=15 Participants
94.2 units on a scale
STANDARD_DEVIATION 17.78 • n=14 Participants
103.9 units on a scale
STANDARD_DEVIATION 13.99 • n=16 Participants
105.9 units on a scale
STANDARD_DEVIATION 14.53 • n=14 Participants
97.97 units on a scale
STANDARD_DEVIATION 16.417 • n=59 Participants
TCI NS-1
27.760 units on a scale
STANDARD_DEVIATION 5.4779 • n=15 Participants
29.385 units on a scale
STANDARD_DEVIATION 5.3000 • n=14 Participants
34.200 units on a scale
STANDARD_DEVIATION 5.7595 • n=16 Participants
35.857 units on a scale
STANDARD_DEVIATION 5.8159 • n=14 Participants
31.814 units on a scale
STANDARD_DEVIATION 6.4070 • n=59 Participants
TCI NS-2
19.60 units on a scale
STANDARD_DEVIATION 4.137 • n=15 Participants
20.85 units on a scale
STANDARD_DEVIATION 6.053 • n=14 Participants
22.93 units on a scale
STANDARD_DEVIATION 4.698 • n=16 Participants
22.79 units on a scale
STANDARD_DEVIATION 5.860 • n=14 Participants
21.54 units on a scale
STANDARD_DEVIATION 5.258 • n=59 Participants
TCI NS-3
23.873 units on a scale
STANDARD_DEVIATION 6.9297 • n=15 Participants
25.231 units on a scale
STANDARD_DEVIATION 8.8615 • n=14 Participants
26.667 units on a scale
STANDARD_DEVIATION 5.5891 • n=16 Participants
26.571 units on a scale
STANDARD_DEVIATION 4.3273 • n=14 Participants
25.581 units on a scale
STANDARD_DEVIATION 6.5084 • n=59 Participants
TCI NS-4
16.73 units on a scale
STANDARD_DEVIATION 3.973 • n=15 Participants
18.77 units on a scale
STANDARD_DEVIATION 3.468 • n=14 Participants
20.07 units on a scale
STANDARD_DEVIATION 5.311 • n=16 Participants
20.64 units on a scale
STANDARD_DEVIATION 4.551 • n=14 Participants
19.04 units on a scale
STANDARD_DEVIATION 4.555 • n=59 Participants
BIS attention-1
10.393 units on a scale
STANDARD_DEVIATION 2.3053 • n=15 Participants
9.929 units on a scale
STANDARD_DEVIATION 1.9400 • n=14 Participants
9.620 units on a scale
STANDARD_DEVIATION 1.9879 • n=16 Participants
11.000 units on a scale
STANDARD_DEVIATION 2.3205 • n=14 Participants
10.225 units on a scale
STANDARD_DEVIATION 2.1500 • n=59 Participants
BIS cognitive instability
5.143 units on a scale
STANDARD_DEVIATION 1.7913 • n=15 Participants
5.536 units on a scale
STANDARD_DEVIATION 1.9852 • n=14 Participants
4.467 units on a scale
STANDARD_DEVIATION 1.1255 • n=16 Participants
5.857 units on a scale
STANDARD_DEVIATION 1.5619 • n=14 Participants
5.237 units on a scale
STANDARD_DEVIATION 1.6800 • n=59 Participants
BIS motor-1
12.714 units on a scale
STANDARD_DEVIATION 2.6144 • n=15 Participants
12.786 units on a scale
STANDARD_DEVIATION 2.9136 • n=14 Participants
12.133 units on a scale
STANDARD_DEVIATION 2.2636 • n=16 Participants
12.071 units on a scale
STANDARD_DEVIATION 2.9733 • n=14 Participants
12.421 units on a scale
STANDARD_DEVIATION 2.6454 • n=59 Participants
BIS perseverance
6.643 units on a scale
STANDARD_DEVIATION 1.5984 • n=15 Participants
6.857 units on a scale
STANDARD_DEVIATION 1.6104 • n=14 Participants
6.847 units on a scale
STANDARD_DEVIATION 1.4426 • n=16 Participants
7.693 units on a scale
STANDARD_DEVIATION 1.9408 • n=14 Participants
7.007 units on a scale
STANDARD_DEVIATION 1.6593 • n=59 Participants
BIS self control
11.071 units on a scale
STANDARD_DEVIATION 3.2455 • n=15 Participants
10.429 units on a scale
STANDARD_DEVIATION 3.0813 • n=14 Participants
11.067 units on a scale
STANDARD_DEVIATION 3.6345 • n=16 Participants
12.357 units on a scale
STANDARD_DEVIATION 3.2959 • n=14 Participants
11.228 units on a scale
STANDARD_DEVIATION 3.3113 • n=59 Participants
BIS cognitive complexity
9.786 units on a scale
STANDARD_DEVIATION 2.0069 • n=15 Participants
10.161 units on a scale
STANDARD_DEVIATION 2.9509 • n=14 Participants
9.933 units on a scale
STANDARD_DEVIATION 2.3442 • n=16 Participants
10.554 units on a scale
STANDARD_DEVIATION 2.4143 • n=14 Participants
10.105 units on a scale
STANDARD_DEVIATION 2.4016 • n=59 Participants
BIS Attention-2
15.536 units on a scale
STANDARD_DEVIATION 3.6187 • n=15 Participants
15.464 units on a scale
STANDARD_DEVIATION 2.7767 • n=14 Participants
14.087 units on a scale
STANDARD_DEVIATION 2.8332 • n=16 Participants
16.857 units on a scale
STANDARD_DEVIATION 3.2548 • n=14 Participants
15.461 units on a scale
STANDARD_DEVIATION 3.2078 • n=59 Participants
BIS Motor-2
19.357 units on a scale
STANDARD_DEVIATION 3.2959 • n=15 Participants
19.643 units on a scale
STANDARD_DEVIATION 3.5865 • n=14 Participants
18.980 units on a scale
STANDARD_DEVIATION 2.8016 • n=16 Participants
19.764 units on a scale
STANDARD_DEVIATION 3.7056 • n=14 Participants
19.428 units on a scale
STANDARD_DEVIATION 3.2791 • n=59 Participants
BIS Non-planning-2
20.857 units on a scale
STANDARD_DEVIATION 4.1668 • n=15 Participants
20.589 units on a scale
STANDARD_DEVIATION 5.2638 • n=14 Participants
21.000 units on a scale
STANDARD_DEVIATION 5.7446 • n=16 Participants
22.911 units on a scale
STANDARD_DEVIATION 4.1459 • n=14 Participants
21.333 units on a scale
STANDARD_DEVIATION 4.8528 • n=59 Participants
MASQ total
173.727 units on a scale
STANDARD_DEVIATION 14.2367 • n=15 Participants
174.077 units on a scale
STANDARD_DEVIATION 18.5448 • n=14 Participants
92.350 units on a scale
STANDARD_DEVIATION 16.0618 • n=16 Participants
88.571 units on a scale
STANDARD_DEVIATION 12.4389 • n=14 Participants
131.476 units on a scale
STANDARD_DEVIATION 44.6597 • n=59 Participants
MASQ GDA
21.800 units on a scale
STANDARD_DEVIATION 6.2244 • n=15 Participants
23.385 units on a scale
STANDARD_DEVIATION 6.7520 • n=14 Participants
14.200 units on a scale
STANDARD_DEVIATION 3.3209 • n=16 Participants
12.071 units on a scale
STANDARD_DEVIATION 1.9793 • n=14 Participants
17.772 units on a scale
STANDARD_DEVIATION 6.8060 • n=59 Participants
MASQ GDD
41.960 units on a scale
STANDARD_DEVIATION 7.7346 • n=15 Participants
39.538 units on a scale
STANDARD_DEVIATION 7.2872 • n=14 Participants
14.533 units on a scale
STANDARD_DEVIATION 3.6029 • n=16 Participants
14.214 units on a scale
STANDARD_DEVIATION 2.9136 • n=14 Participants
27.375 units on a scale
STANDARD_DEVIATION 14.5034 • n=59 Participants
MASQ AA
21.880 units on a scale
STANDARD_DEVIATION 2.9644 • n=15 Participants
23.385 units on a scale
STANDARD_DEVIATION 4.4260 • n=14 Participants
19.417 units on a scale
STANDARD_DEVIATION 3.3643 • n=16 Participants
17.643 units on a scale
STANDARD_DEVIATION 1.1507 • n=14 Participants
20.534 units on a scale
STANDARD_DEVIATION 3.7852 • n=59 Participants
MASQ AD
88.087 units on a scale
STANDARD_DEVIATION 9.1143 • n=15 Participants
87.769 units on a scale
STANDARD_DEVIATION 6.9180 • n=14 Participants
44.200 units on a scale
STANDARD_DEVIATION 8.4448 • n=16 Participants
44.643 units on a scale
STANDARD_DEVIATION 9.6764 • n=14 Participants
65.795 units on a scale
STANDARD_DEVIATION 23.5064 • n=59 Participants
RSES_Total
26.36 units on a scale
STANDARD_DEVIATION 4.802 • n=15 Participants
26.36 units on a scale
STANDARD_DEVIATION 5.988 • n=14 Participants
14.14 units on a scale
STANDARD_DEVIATION 3.891 • n=16 Participants
14.33 units on a scale
STANDARD_DEVIATION 4.633 • n=14 Participants
21.86 units on a scale
STANDARD_DEVIATION 7.651 • n=59 Participants
Defeat Scale
38.09 units on a scale
STANDARD_DEVIATION 6.700 • n=15 Participants
35.55 units on a scale
STANDARD_DEVIATION 9.720 • n=14 Participants
5.88 units on a scale
STANDARD_DEVIATION 3.182 • n=16 Participants
5.25 units on a scale
STANDARD_DEVIATION 5.392 • n=14 Participants
23.66 units on a scale
STANDARD_DEVIATION 17.049 • n=59 Participants
BDI-II
24.40 units on a scale
STANDARD_DEVIATION 8.423 • n=15 Participants
27.91 units on a scale
STANDARD_DEVIATION 7.877 • n=14 Participants
1.31 units on a scale
STANDARD_DEVIATION 2.387 • n=16 Participants
1.51 units on a scale
STANDARD_DEVIATION 3.131 • n=14 Participants
13.54 units on a scale
STANDARD_DEVIATION 13.828 • n=59 Participants
SHPS total
32.753 units on a scale
STANDARD_DEVIATION 4.6489 • n=15 Participants
32.450 units on a scale
STANDARD_DEVIATION 7.5103 • n=14 Participants
21.293 units on a scale
STANDARD_DEVIATION 5.6623 • n=16 Participants
23.714 units on a scale
STANDARD_DEVIATION 7.4258 • n=14 Participants
27.534 units on a scale
STANDARD_DEVIATION 8.0970 • n=59 Participants
SHPS-low
7.667 Count of 'low' responses (1 or 2)
STANDARD_DEVIATION 1.3452 • n=15 Participants
6.857 Count of 'low' responses (1 or 2)
STANDARD_DEVIATION 1.0995 • n=14 Participants
6.400 Count of 'low' responses (1 or 2)
STANDARD_DEVIATION 1.8439 • n=16 Participants
6.571 Count of 'low' responses (1 or 2)
STANDARD_DEVIATION 2.9013 • n=14 Participants
6.879 Count of 'low' responses (1 or 2)
STANDARD_DEVIATION 1.9293 • n=59 Participants
AES
43.45 units on a scale
STANDARD_DEVIATION 7.063 • n=15 Participants
42.14 units on a scale
STANDARD_DEVIATION 4.786 • n=14 Participants
59.53 units on a scale
STANDARD_DEVIATION 4.856 • n=16 Participants
60.86 units on a scale
STANDARD_DEVIATION 4.400 • n=14 Participants
51.63 units on a scale
STANDARD_DEVIATION 10.218 • n=59 Participants
Current smokers
0 Participants
n=15 Participants
0 Participants
n=14 Participants
0 Participants
n=16 Participants
0 Participants
n=14 Participants
0 Participants
n=59 Participants
Past smokers
0 Participants
n=15 Participants
1 Participants
n=14 Participants
0 Participants
n=16 Participants
0 Participants
n=14 Participants
1 Participants
n=59 Participants
Current drinkers
4 Participants
n=15 Participants
6 Participants
n=14 Participants
5 Participants
n=16 Participants
4 Participants
n=14 Participants
19 Participants
n=59 Participants
Drinks in past 24hrs
0.29 equivalent shot/can/glasses
STANDARD_DEVIATION 0.469 • n=15 Participants
0.46 equivalent shot/can/glasses
STANDARD_DEVIATION 0.519 • n=14 Participants
0.36 equivalent shot/can/glasses
STANDARD_DEVIATION 0.497 • n=16 Participants
0.29 equivalent shot/can/glasses
STANDARD_DEVIATION 0.469 • n=14 Participants
0.35 equivalent shot/can/glasses
STANDARD_DEVIATION 0.480 • n=59 Participants
Usual caffeine (mg)
124.35 milligrams
STANDARD_DEVIATION 74.162 • n=15 Participants
176.50 milligrams
STANDARD_DEVIATION 87.444 • n=14 Participants
82.93 milligrams
STANDARD_DEVIATION 77.308 • n=16 Participants
64.75 milligrams
STANDARD_DEVIATION 41.139 • n=14 Participants
111.05 milligrams
STANDARD_DEVIATION 111.05 • n=59 Participants
Caffeine today (mg)
81.23 milligrams
STANDARD_DEVIATION 83.400 • n=15 Participants
102.88 milligrams
STANDARD_DEVIATION 108.938 • n=14 Participants
32.13 milligrams
STANDARD_DEVIATION 32.335 • n=16 Participants
67.23 milligrams
STANDARD_DEVIATION 67.268 • n=14 Participants
69.44 milligrams
STANDARD_DEVIATION 79.159 • n=59 Participants

PRIMARY outcome

Timeframe: administered after scan

Population: Reward-learning results are missing for 7 subjects

This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from rewards during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from reward trials.

Outcome measures

Outcome measures
Measure
MDD-amisulpride
n=14 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=12 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=15 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=11 Participants
Subjects having no history of mental disorder who received placebo
Effect on PST Reward Learning
0.6271 Effect size (Beta)
Standard Deviation 0.15608
0.7575 Effect size (Beta)
Standard Deviation 0.1676
0.823 Effect size (Beta)
Standard Deviation 0.1228
0.7545 Effect size (Beta)
Standard Deviation 0.1828

PRIMARY outcome

Timeframe: administered after scan

Population: Penalty-learning results are missing for 7 subjects

This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from penalties during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from penalty trials.

Outcome measures

Outcome measures
Measure
MDD-amisulpride
n=14 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=12 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=15 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=11 Participants
Subjects having no history of mental disorder who received placebo
Effect on PST Penalty Learning
0.2428 Effect size (Beta)
Standard Deviation 0.1800
0.29 Effect size (Beta)
Standard Deviation 0.2056
0.2207 Effect size (Beta)
Standard Deviation 0.20225
0.2391 Effect size (Beta)
Standard Deviation 0.14618

PRIMARY outcome

Timeframe: Scan session

Population: Data are missing for 8 subjects due to poor MRI quality.

This statistic shows the effect (beta) that the combination of diagnosis and drug has on caudate activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline.

Outcome measures

Outcome measures
Measure
MDD-amisulpride
n=13 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=11 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=16 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=11 Participants
Subjects having no history of mental disorder who received placebo
Effect on Caudate Response to Cues
0.2231 Effect size (Beta)
Standard Deviation 0.42189
-0.0391 Effect size (Beta)
Standard Deviation 0.32792
-0.0938 Effect size (Beta)
Standard Deviation 0.57788
0.0582 Effect size (Beta)
Standard Deviation 0.30318

PRIMARY outcome

Timeframe: Scan session

Population: Data are missing for 8 subjects due to poor MRI quality

This statistic shows the effect (beta) that the combination of diagnosis and drug has on nucleus accumbens (NAcc) activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline.

Outcome measures

Outcome measures
Measure
MDD-amisulpride
n=13 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=11 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=16 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=11 Participants
Subjects having no history of mental disorder who received placebo
Effect on NAcc Response to Cues
0.2446 Effect size (Beta)
Standard Deviation 0.38546
0.0736 Effect size (Beta)
Standard Deviation 0.38694
0.1356 Effect size (Beta)
Standard Deviation 0.51800
0.2182 Effect size (Beta)
Standard Deviation 0.55236

PRIMARY outcome

Timeframe: Scan session

Population: Data are missing for 9 subjects due to poor MRI quality

This statistic shows the effect (beta) that the combination of diagnosis and drug has on putamen activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline.

Outcome measures

Outcome measures
Measure
MDD-amisulpride
n=13 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=11 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=16 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=10 Participants
Subjects having no history of mental disorder who received placebo
Putamen Response to Cues
0.4969 Effect size (Beta)
Standard Deviation 0.41086
0.3955 Effect size (Beta)
Standard Deviation 0.36653
0.4169 Effect size (Beta)
Standard Deviation 0.41839
0.3808 Effect size (Beta)
Standard Deviation 0.42303

PRIMARY outcome

Timeframe: During scan session

Population: Data are missing for 9 subjects due to poor MRI quality

This statistic shows the effect (beta) that the combination of diagnosis and drug has on caudate activation after Reward outcomes. Positive values indicate an increase in activation relative to baseline.

Outcome measures

Outcome measures
Measure
MDD-amisulpride
n=12 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=11 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=16 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=11 Participants
Subjects having no history of mental disorder who received placebo
Effect on Caudate Response to Reward
0.5783 Effect size (Beta)
Standard Deviation 1.0104
-0.2673 Effect size (Beta)
Standard Deviation 0.1575
-0.33 Effect size (Beta)
Standard Deviation 1.243
0.1955 Effect size (Beta)
Standard Deviation 0.1101

PRIMARY outcome

Timeframe: During scan session

Population: Data are missing for 10 subjects due to poor MRI quality

This statistic shows the effect (beta) that the combination of diagnosis and drug has on nucleus accumbens (NAcc) activation after reward outcomes. Positive values indicate an increase in activation relative to baseline.

Outcome measures

Outcome measures
Measure
MDD-amisulpride
n=13 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=10 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=16 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=10 Participants
Subjects having no history of mental disorder who received placebo
Effect on NAcc Response to Reward
0.9377 Effect size (Beta)
Standard Deviation 0.1357
0.1578 Effect size (Beta)
Standard Deviation 0.8534
0.4018 Effect size (Beta)
Standard Deviation 1.2619
0.954 Effect size (Beta)
Standard Deviation 1.0833

PRIMARY outcome

Timeframe: During scan session

Population: Data are missing for 9 subjects due to poor MRI quality

This statistic shows the effect (beta) that the combination of diagnosis and drug has on putamen activation (beta) after reward outcomes. Positive values indicate an increase in activation relative to baseline.

Outcome measures

Outcome measures
Measure
MDD-amisulpride
n=13 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=11 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=16 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=10 Participants
Subjects having no history of mental disorder who received placebo
Effect on Putamen Response to Reward
0.6338 Effect size (Beta)
Standard Deviation 0.8394
0.1709 Effect size (Beta)
Standard Deviation 0.7996
-0.14 Effect size (Beta)
Standard Deviation 1.2282
0.436 Effect size (Beta)
Standard Deviation 0.6689

SECONDARY outcome

Timeframe: During scan session

Population: Data missing for 8 subjects due to poor MRI quality

This statistic shows the effect (beta) that the combination of diagnosis and drug has on functional connectivity between caudate and dorsal anterior cingulate cortex (dACC) in response to reward outcomes

Outcome measures

Outcome measures
Measure
MDD-amisulpride
n=14 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=11 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=13 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=13 Participants
Subjects having no history of mental disorder who received placebo
Effect on Caudate-dACC Connectivity After Reward
0.3628 Effect size (Beta)
Standard Deviation 0.4057
0.3881 Effect size (Beta)
Standard Deviation 0.3415
0.2992 Effect size (Beta)
Standard Deviation 0.49098
0.6192 Effect size (Beta)
Standard Deviation 0.4270

SECONDARY outcome

Timeframe: During scan session

Population: Data missing for 8 subjects due to poor MRI quality

This statistic shows the effect (beta) that the combination of diagnosis and drug has on functional connectivity between nucleus accumbens (NAcc) and mid-cingulate cortex (MCC) in response to reward outcomes.

Outcome measures

Outcome measures
Measure
MDD-amisulpride
n=14 Participants
Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo
n=11 Participants
Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride
n=13 Participants
Subjects having no history of mental disorder who received amisulpride
HC-placebo
n=13 Participants
Subjects having no history of mental disorder who received placebo
Effect on NAcc-MCC Connectivity After Reward
0.4375 Effect size (Beta)
Standard Deviation 0.4163
0.324 Effect size (Beta)
Standard Deviation 0.4992
0.4846 Effect size (Beta)
Standard Deviation 0.6279
0.4877 Effect size (Beta)
Standard Deviation 0.5070

Adverse Events

MDD-amisulpride

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MDD-placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

HC-amisulpride

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

HC-placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Diego Pizzagalli, Ph.D.

McLean Hospital

Phone: 617-855-4230

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place