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.
COMPLETED
PHASE1
159 participants
administered after scan
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
| 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
| 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
| 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 scanPopulation: 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
| 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 scanPopulation: 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
| 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 sessionPopulation: 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
| 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 sessionPopulation: 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
| 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 sessionPopulation: 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
| 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 sessionPopulation: 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
| 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 sessionPopulation: 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
| 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 sessionPopulation: 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
| 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 sessionPopulation: 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
| 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 sessionPopulation: 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
| 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
MDD-placebo
HC-amisulpride
HC-placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place