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The Effects of Dopamine on Reward Processing

The Effects of Dopamine on Reward Processing

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01253421
Enrollment
159
Registered
2010-12-03
Start date
2012-02-29
Completion date
2016-05-31
Last updated
2018-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder (MDD)

Keywords

MDD, Major Depressive Disorder, Amisulpride

Brief summary

The purpose of this study is to evaluate the effects of a single low dose of the D2/D3 antagonist amisulpride on reward processing. More generally, this study will test the role of dopamine (a naturally occurring brain chemical) in depression. Hypotheses: Administration of a single low dose of the D2/D3 antagonist amisulpride will (1) improve performance in a behavioral task assessing learning from feedback and (2) boost activation in reward-related brain regions.

Detailed description

Through an integration of a functional magnetic resonance imaging (fMRI) approach coupled with a pharmacological challenge, the goal of the current study will be to investigate the role of dopamine in MDD. Participants in this research will include 36 MDD subjects and 36 demographically matched healthy participants recruited from the community by Dr. Pizzagalli's laboratory at McLean Hospital's Center for Depression, Anxiety and Stress Research. This study will include two sessions: * The first session will involve a diagnostic interview, and a series of questionnaires and assessments. * The second session will take place at the McLean Hospital's Neuroimaging Center, and include the administration of a low-dose of amisulpride (50 mg capsule) or placebo, followed by an fMRI brain scan and administration of two behavioral tasks.

Interventions

DRUGamisulpride

single low-dose pharmacological challenge, 50 mg amisulpride

DRUGplacebo

single-dose placebo capsule

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Mclean Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

There were two groups of subjects: currently experiencing a major depressive episode, or normal health controls. The groups were matched for age, gender, and race. Within each group, half of the subjects were assigned to receive the study drug (amisulpride) and half to receive a placebo.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Inclusion Criteria for subjects with Major Depressive Disorder (MDD): 1. Diagnostic and Statistical Manual of Mental Disorders (DSM IV) diagnostic criteria for MDD, diagnosed with the use of the Structured Clinical Interview for DSM Disorders (SCID); 2. Written informed consent; 3. Both genders and all ethnic origins, age between 18 and 45; 4. A baseline score \> 16 on the Hamilton Rating Scale for Depression (HRSD) 17-item version; 5. Right-handed. 6. Absence of any psychotropic medications for at least 2 weeks: * 6 weeks for fluoxetine, * 6 months for neuroleptics, * 2 weeks for benzodiazepines, * 2 weeks for any other antidepressants. Inclusion Criteria for Control Subjects: 1. Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP); 2. Written informed consent; 3. Both genders and all ethnic origins, age between 18 and 45; 4. Right-handed; 5. Absence of any medications for at least 3 weeks; 6. Absence of pregnancy.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Effect on Putamen Response to RewardDuring scan sessionThis 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.
Effect on Caudate Response to RewardDuring scan sessionThis 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.
Effect on NAcc Response to RewardDuring scan sessionThis 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.
Effect on PST Reward Learningadministered after scanThis 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.
Effect on PST Penalty Learningadministered after scanThis 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.
Effect on Caudate Response to CuesScan sessionThis 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.
Effect on NAcc Response to CuesScan sessionThis 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.
Putamen Response to CuesScan sessionThis 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.

Secondary

MeasureTime frameDescription
Effect on NAcc-MCC Connectivity After RewardDuring scan sessionThis 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.
Effect on Caudate-dACC Connectivity After RewardDuring scan sessionThis 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

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
MDD-amisulpride
Subjects experiencing a current episode of major depression who received amisulpride
15
MDD-placebo
Subjects experiencing a current episode of major depression who received placebo
14
HC-amisulpride
Subjects having no history of mental disorder who received amisulpride
16
HC-placebo
Subjects having no history of mental disorder who received placebo
14
Total59

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Assessment and SchedulingFound to be Ineligible740000
Assessment and SchedulingLost to Follow-up170000
Assessment and SchedulingPhysician Decision10000
Assessment and SchedulingWithdrawal by Subject70000
Drug+Scanning VisitPhysician Decision00001

Baseline characteristics

CharacteristicMDD-placeboHC-amisulprideHC-placeboTotalMDD-amisulpride
AES42.14 units on a scale
STANDARD_DEVIATION 4.786
59.53 units on a scale
STANDARD_DEVIATION 4.856
60.86 units on a scale
STANDARD_DEVIATION 4.4
51.63 units on a scale
STANDARD_DEVIATION 10.218
43.45 units on a scale
STANDARD_DEVIATION 7.063
Age, Continuous25.8 years
STANDARD_DEVIATION 5.35
25.3 years
STANDARD_DEVIATION 25.3
24.7 years
STANDARD_DEVIATION 24.7
26 years
STANDARD_DEVIATION 6.79
27.20 years
STANDARD_DEVIATION 8.6
BDI-II27.91 units on a scale
STANDARD_DEVIATION 7.877
1.31 units on a scale
STANDARD_DEVIATION 2.387
1.51 units on a scale
STANDARD_DEVIATION 3.131
13.54 units on a scale
STANDARD_DEVIATION 13.828
24.40 units on a scale
STANDARD_DEVIATION 8.423
BIS attention-19.929 units on a scale
STANDARD_DEVIATION 1.94
9.620 units on a scale
STANDARD_DEVIATION 1.9879
11.000 units on a scale
STANDARD_DEVIATION 2.3205
10.225 units on a scale
STANDARD_DEVIATION 2.15
10.393 units on a scale
STANDARD_DEVIATION 2.3053
BIS Attention-215.464 units on a scale
STANDARD_DEVIATION 2.7767
14.087 units on a scale
STANDARD_DEVIATION 2.8332
16.857 units on a scale
STANDARD_DEVIATION 3.2548
15.461 units on a scale
STANDARD_DEVIATION 3.2078
15.536 units on a scale
STANDARD_DEVIATION 3.6187
BIS cognitive complexity10.161 units on a scale
STANDARD_DEVIATION 2.9509
9.933 units on a scale
STANDARD_DEVIATION 2.3442
10.554 units on a scale
STANDARD_DEVIATION 2.4143
10.105 units on a scale
STANDARD_DEVIATION 2.4016
9.786 units on a scale
STANDARD_DEVIATION 2.0069
BIS cognitive instability5.536 units on a scale
STANDARD_DEVIATION 1.9852
4.467 units on a scale
STANDARD_DEVIATION 1.1255
5.857 units on a scale
STANDARD_DEVIATION 1.5619
5.237 units on a scale
STANDARD_DEVIATION 1.68
5.143 units on a scale
STANDARD_DEVIATION 1.7913
BIS motor-112.786 units on a scale
STANDARD_DEVIATION 2.9136
12.133 units on a scale
STANDARD_DEVIATION 2.2636
12.071 units on a scale
STANDARD_DEVIATION 2.9733
12.421 units on a scale
STANDARD_DEVIATION 2.6454
12.714 units on a scale
STANDARD_DEVIATION 2.6144
BIS Motor-219.643 units on a scale
STANDARD_DEVIATION 3.5865
18.980 units on a scale
STANDARD_DEVIATION 2.8016
19.764 units on a scale
STANDARD_DEVIATION 3.7056
19.428 units on a scale
STANDARD_DEVIATION 3.2791
19.357 units on a scale
STANDARD_DEVIATION 3.2959
BIS Non-planning-220.589 units on a scale
STANDARD_DEVIATION 5.2638
21.000 units on a scale
STANDARD_DEVIATION 5.7446
22.911 units on a scale
STANDARD_DEVIATION 4.1459
21.333 units on a scale
STANDARD_DEVIATION 4.8528
20.857 units on a scale
STANDARD_DEVIATION 4.1668
BIS perseverance6.857 units on a scale
STANDARD_DEVIATION 1.6104
6.847 units on a scale
STANDARD_DEVIATION 1.4426
7.693 units on a scale
STANDARD_DEVIATION 1.9408
7.007 units on a scale
STANDARD_DEVIATION 1.6593
6.643 units on a scale
STANDARD_DEVIATION 1.5984
BIS self control10.429 units on a scale
STANDARD_DEVIATION 3.0813
11.067 units on a scale
STANDARD_DEVIATION 3.6345
12.357 units on a scale
STANDARD_DEVIATION 3.2959
11.228 units on a scale
STANDARD_DEVIATION 3.3113
11.071 units on a scale
STANDARD_DEVIATION 3.2455
Caffeine today (mg)102.88 milligrams
STANDARD_DEVIATION 108.938
32.13 milligrams
STANDARD_DEVIATION 32.335
67.23 milligrams
STANDARD_DEVIATION 67.268
69.44 milligrams
STANDARD_DEVIATION 79.159
81.23 milligrams
STANDARD_DEVIATION 83.4
Current drinkers6 Participants5 Participants4 Participants19 Participants4 Participants
Current smokers0 Participants0 Participants0 Participants0 Participants0 Participants
Defeat Scale35.55 units on a scale
STANDARD_DEVIATION 9.72
5.88 units on a scale
STANDARD_DEVIATION 3.182
5.25 units on a scale
STANDARD_DEVIATION 5.392
23.66 units on a scale
STANDARD_DEVIATION 17.049
38.09 units on a scale
STANDARD_DEVIATION 6.7
Drinks in past 24hrs0.46 equivalent shot/can/glasses
STANDARD_DEVIATION 0.519
0.36 equivalent shot/can/glasses
STANDARD_DEVIATION 0.497
0.29 equivalent shot/can/glasses
STANDARD_DEVIATION 0.469
0.35 equivalent shot/can/glasses
STANDARD_DEVIATION 0.48
0.29 equivalent shot/can/glasses
STANDARD_DEVIATION 0.469
Educ-yrs16.6 years
STANDARD_DEVIATION 2.9
16.2 years
STANDARD_DEVIATION 2.13
16.5 years
STANDARD_DEVIATION 1.52
16.2 years
STANDARD_DEVIATION 2.18
15.6 years
STANDARD_DEVIATION 2.06
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants3 Participants0 Participants7 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants12 Participants14 Participants51 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants0 Participants
HRSD18.4 units on a scale
STANDARD_DEVIATION 5.09
1.0 units on a scale
STANDARD_DEVIATION 1.58
0.5 units on a scale
STANDARD_DEVIATION 0.66
9.37 units on a scale
STANDARD_DEVIATION 8.997
16.4 units on a scale
STANDARD_DEVIATION 3.37
Length_MDE14.00 months
STANDARD_DEVIATION 18.982
16.17 months
STANDARD_DEVIATION 17.771
20.50 months
STANDARD_DEVIATION 16.53
MASQ AA23.385 units on a scale
STANDARD_DEVIATION 4.426
19.417 units on a scale
STANDARD_DEVIATION 3.3643
17.643 units on a scale
STANDARD_DEVIATION 1.1507
20.534 units on a scale
STANDARD_DEVIATION 3.7852
21.880 units on a scale
STANDARD_DEVIATION 2.9644
MASQ AD87.769 units on a scale
STANDARD_DEVIATION 6.918
44.200 units on a scale
STANDARD_DEVIATION 8.4448
44.643 units on a scale
STANDARD_DEVIATION 9.6764
65.795 units on a scale
STANDARD_DEVIATION 23.5064
88.087 units on a scale
STANDARD_DEVIATION 9.1143
MASQ GDA23.385 units on a scale
STANDARD_DEVIATION 6.752
14.200 units on a scale
STANDARD_DEVIATION 3.3209
12.071 units on a scale
STANDARD_DEVIATION 1.9793
17.772 units on a scale
STANDARD_DEVIATION 6.806
21.800 units on a scale
STANDARD_DEVIATION 6.2244
MASQ GDD39.538 units on a scale
STANDARD_DEVIATION 7.2872
14.533 units on a scale
STANDARD_DEVIATION 3.6029
14.214 units on a scale
STANDARD_DEVIATION 2.9136
27.375 units on a scale
STANDARD_DEVIATION 14.5034
41.960 units on a scale
STANDARD_DEVIATION 7.7346
MASQ total174.077 units on a scale
STANDARD_DEVIATION 18.5448
92.350 units on a scale
STANDARD_DEVIATION 16.0618
88.571 units on a scale
STANDARD_DEVIATION 12.4389
131.476 units on a scale
STANDARD_DEVIATION 44.6597
173.727 units on a scale
STANDARD_DEVIATION 14.2367
MDD SCID rating2.9 units on a scale
STANDARD_DEVIATION 0.27
1 units on a scale
STANDARD_DEVIATION 0
1 units on a scale
STANDARD_DEVIATION 0
1.93 units on a scale
STANDARD_DEVIATION 0.99
2.9 units on a scale
STANDARD_DEVIATION 0.27
# MDEs4.79 Episodes
STANDARD_DEVIATION 3.49
3.74 Episodes
STANDARD_DEVIATION 3.23
2.75 Episodes
STANDARD_DEVIATION 2.667
Menstrual phase
Follicular
2 Participants6 Participants3 Participants12 Participants1 Participants
Menstrual phase
Luteal
1 Participants1 Participants3 Participants9 Participants4 Participants
Menstrual phase
Unknown
3 Participants4 Participants3 Participants17 Participants7 Participants
Past smokers1 Participants0 Participants0 Participants1 Participants0 Participants
Patients with comorbid anxiety disorder
Has comorbid Anxiety Disorder
6 Participants0 Participants0 Participants9 Participants3 Participants
Patients with comorbid anxiety disorder
No comorbid Anxiety Disorder
8 Participants16 Participants14 Participants47 Participants9 Participants
Patients with comorbid anxiety disorder
Unknown
0 Participants0 Participants0 Participants3 Participants3 Participants
Patients with past anxiety disorder
No
8 Participants16 Participants14 Participants47 Participants9 Participants
Patients with past anxiety disorder
Unknown
0 Participants0 Participants0 Participants3 Participants3 Participants
Patients with past anxiety disorder
Yes
6 Participants0 Participants0 Participants9 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants5 Participants9 Participants2 Participants
Race (NIH/OMB)
Black or African American
2 Participants3 Participants3 Participants9 Participants1 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants3 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
White
9 Participants10 Participants6 Participants36 Participants11 Participants
Region of Enrollment
United States
14 Participants16 Participants14 Participants59 Participants15 Participants
RSES_Total26.36 units on a scale
STANDARD_DEVIATION 5.988
14.14 units on a scale
STANDARD_DEVIATION 3.891
14.33 units on a scale
STANDARD_DEVIATION 4.633
21.86 units on a scale
STANDARD_DEVIATION 7.651
26.36 units on a scale
STANDARD_DEVIATION 4.802
Sex: Female, Male
Female
6 Participants11 Participants9 Participants38 Participants12 Participants
Sex: Female, Male
Male
8 Participants5 Participants5 Participants21 Participants3 Participants
SHPS-low6.857 Count of 'low' responses (1 or 2)
STANDARD_DEVIATION 1.0995
6.400 Count of 'low' responses (1 or 2)
STANDARD_DEVIATION 1.8439
6.571 Count of 'low' responses (1 or 2)
STANDARD_DEVIATION 2.9013
6.879 Count of 'low' responses (1 or 2)
STANDARD_DEVIATION 1.9293
7.667 Count of 'low' responses (1 or 2)
STANDARD_DEVIATION 1.3452
SHPS total32.450 units on a scale
STANDARD_DEVIATION 7.5103
21.293 units on a scale
STANDARD_DEVIATION 5.6623
23.714 units on a scale
STANDARD_DEVIATION 7.4258
27.534 units on a scale
STANDARD_DEVIATION 8.097
32.753 units on a scale
STANDARD_DEVIATION 4.6489
TCI NS-129.385 units on a scale
STANDARD_DEVIATION 5.3
34.200 units on a scale
STANDARD_DEVIATION 5.7595
35.857 units on a scale
STANDARD_DEVIATION 5.8159
31.814 units on a scale
STANDARD_DEVIATION 6.407
27.760 units on a scale
STANDARD_DEVIATION 5.4779
TCI NS-220.85 units on a scale
STANDARD_DEVIATION 6.053
22.93 units on a scale
STANDARD_DEVIATION 4.698
22.79 units on a scale
STANDARD_DEVIATION 5.86
21.54 units on a scale
STANDARD_DEVIATION 5.258
19.60 units on a scale
STANDARD_DEVIATION 4.137
TCI NS-325.231 units on a scale
STANDARD_DEVIATION 8.8615
26.667 units on a scale
STANDARD_DEVIATION 5.5891
26.571 units on a scale
STANDARD_DEVIATION 4.3273
25.581 units on a scale
STANDARD_DEVIATION 6.5084
23.873 units on a scale
STANDARD_DEVIATION 6.9297
TCI NS-418.77 units on a scale
STANDARD_DEVIATION 3.468
20.07 units on a scale
STANDARD_DEVIATION 5.311
20.64 units on a scale
STANDARD_DEVIATION 4.551
19.04 units on a scale
STANDARD_DEVIATION 4.555
16.73 units on a scale
STANDARD_DEVIATION 3.973
TCI Total94.2 units on a scale
STANDARD_DEVIATION 17.78
103.9 units on a scale
STANDARD_DEVIATION 13.99
105.9 units on a scale
STANDARD_DEVIATION 14.53
97.97 units on a scale
STANDARD_DEVIATION 16.417
87.97 units on a scale
STANDARD_DEVIATION 13.992
Usual caffeine (mg)176.50 milligrams
STANDARD_DEVIATION 87.444
82.93 milligrams
STANDARD_DEVIATION 77.308
64.75 milligrams
STANDARD_DEVIATION 41.139
111.05 milligrams
STANDARD_DEVIATION 111.05
124.35 milligrams
STANDARD_DEVIATION 74.162

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 140 / 160 / 14
other
Total, other adverse events
0 / 150 / 140 / 160 / 14
serious
Total, serious adverse events
0 / 150 / 140 / 160 / 14

Outcome results

Primary

Effect on Caudate Response to Cues

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.

Time frame: Scan session

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

ArmMeasureValue (MEAN)Dispersion
MDD-amisulprideEffect on Caudate Response to Cues0.2231 Effect size (Beta)Standard Deviation 0.42189
MDD-placeboEffect on Caudate Response to Cues-0.0391 Effect size (Beta)Standard Deviation 0.32792
HC-amisulprideEffect on Caudate Response to Cues-0.0938 Effect size (Beta)Standard Deviation 0.57788
HC-placeboEffect on Caudate Response to Cues0.0582 Effect size (Beta)Standard Deviation 0.30318
Primary

Effect on Caudate Response to Reward

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.

Time frame: During scan session

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

ArmMeasureValue (MEAN)Dispersion
MDD-amisulprideEffect on Caudate Response to Reward0.5783 Effect size (Beta)Standard Deviation 1.0104
MDD-placeboEffect on Caudate Response to Reward-0.2673 Effect size (Beta)Standard Deviation 0.1575
HC-amisulprideEffect on Caudate Response to Reward-0.33 Effect size (Beta)Standard Deviation 1.243
HC-placeboEffect on Caudate Response to Reward0.1955 Effect size (Beta)Standard Deviation 0.1101
Primary

Effect on NAcc Response to Cues

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.

Time frame: Scan session

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

ArmMeasureValue (MEAN)Dispersion
MDD-amisulprideEffect on NAcc Response to Cues0.2446 Effect size (Beta)Standard Deviation 0.38546
MDD-placeboEffect on NAcc Response to Cues0.0736 Effect size (Beta)Standard Deviation 0.38694
HC-amisulprideEffect on NAcc Response to Cues0.1356 Effect size (Beta)Standard Deviation 0.518
HC-placeboEffect on NAcc Response to Cues0.2182 Effect size (Beta)Standard Deviation 0.55236
Primary

Effect on NAcc Response to Reward

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.

Time frame: During scan session

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

ArmMeasureValue (MEAN)Dispersion
MDD-amisulprideEffect on NAcc Response to Reward0.9377 Effect size (Beta)Standard Deviation 0.1357
MDD-placeboEffect on NAcc Response to Reward0.1578 Effect size (Beta)Standard Deviation 0.8534
HC-amisulprideEffect on NAcc Response to Reward0.4018 Effect size (Beta)Standard Deviation 1.2619
HC-placeboEffect on NAcc Response to Reward0.954 Effect size (Beta)Standard Deviation 1.0833
Primary

Effect on PST Penalty Learning

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.

Time frame: administered after scan

Population: Penalty-learning results are missing for 7 subjects

ArmMeasureValue (MEAN)Dispersion
MDD-amisulprideEffect on PST Penalty Learning0.2428 Effect size (Beta)Standard Deviation 0.18
MDD-placeboEffect on PST Penalty Learning0.29 Effect size (Beta)Standard Deviation 0.2056
HC-amisulprideEffect on PST Penalty Learning0.2207 Effect size (Beta)Standard Deviation 0.20225
HC-placeboEffect on PST Penalty Learning0.2391 Effect size (Beta)Standard Deviation 0.14618
Primary

Effect on PST Reward Learning

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.

Time frame: administered after scan

Population: Reward-learning results are missing for 7 subjects

ArmMeasureValue (MEAN)Dispersion
MDD-amisulprideEffect on PST Reward Learning0.6271 Effect size (Beta)Standard Deviation 0.15608
MDD-placeboEffect on PST Reward Learning0.7575 Effect size (Beta)Standard Deviation 0.1676
HC-amisulprideEffect on PST Reward Learning0.823 Effect size (Beta)Standard Deviation 0.1228
HC-placeboEffect on PST Reward Learning0.7545 Effect size (Beta)Standard Deviation 0.1828
Primary

Effect on Putamen Response to Reward

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.

Time frame: During scan session

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

ArmMeasureValue (MEAN)Dispersion
MDD-amisulprideEffect on Putamen Response to Reward0.6338 Effect size (Beta)Standard Deviation 0.8394
MDD-placeboEffect on Putamen Response to Reward0.1709 Effect size (Beta)Standard Deviation 0.7996
HC-amisulprideEffect on Putamen Response to Reward-0.14 Effect size (Beta)Standard Deviation 1.2282
HC-placeboEffect on Putamen Response to Reward0.436 Effect size (Beta)Standard Deviation 0.6689
Primary

Putamen Response to Cues

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.

Time frame: Scan session

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

ArmMeasureValue (MEAN)Dispersion
MDD-amisulpridePutamen Response to Cues0.4969 Effect size (Beta)Standard Deviation 0.41086
MDD-placeboPutamen Response to Cues0.3955 Effect size (Beta)Standard Deviation 0.36653
HC-amisulpridePutamen Response to Cues0.4169 Effect size (Beta)Standard Deviation 0.41839
HC-placeboPutamen Response to Cues0.3808 Effect size (Beta)Standard Deviation 0.42303
Secondary

Effect on Caudate-dACC Connectivity After Reward

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

Time frame: During scan session

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

ArmMeasureValue (MEAN)Dispersion
MDD-amisulprideEffect on Caudate-dACC Connectivity After Reward0.3628 Effect size (Beta)Standard Deviation 0.4057
MDD-placeboEffect on Caudate-dACC Connectivity After Reward0.3881 Effect size (Beta)Standard Deviation 0.3415
HC-amisulprideEffect on Caudate-dACC Connectivity After Reward0.2992 Effect size (Beta)Standard Deviation 0.49098
HC-placeboEffect on Caudate-dACC Connectivity After Reward0.6192 Effect size (Beta)Standard Deviation 0.427
Secondary

Effect on NAcc-MCC Connectivity After Reward

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.

Time frame: During scan session

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

ArmMeasureValue (MEAN)Dispersion
MDD-amisulprideEffect on NAcc-MCC Connectivity After Reward0.4375 Effect size (Beta)Standard Deviation 0.4163
MDD-placeboEffect on NAcc-MCC Connectivity After Reward0.324 Effect size (Beta)Standard Deviation 0.4992
HC-amisulprideEffect on NAcc-MCC Connectivity After Reward0.4846 Effect size (Beta)Standard Deviation 0.6279
HC-placeboEffect on NAcc-MCC Connectivity After Reward0.4877 Effect size (Beta)Standard Deviation 0.507

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026