Major Depressive Disorder (MDD)Phase 1NCT01253421

The Effects of Dopamine on Reward Processing

A Phase 1 study testing amisulpride in people with Major Depressive Disorder (MDD), run by Mclean Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder (MDD)
What is being tested?: amisulpride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 159 participants
Where: 1 siteUnited States
Study dates: Feb 2012to May 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Inclusion Criteria for subjects with Major Depressive Disorder (MDD):
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);
Written informed consent;
Both genders and all ethnic origins, age between 18 and 45;
A baseline score > 16 on the Hamilton Rating Scale for Depression (HRSD) 17-item version;
Right-handed.

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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.
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);
Written informed consent;
Both genders and all ethnic origins, age between 18 and 45;
Right-handed;
Absence of any medications for at least 3 weeks;
Absence of pregnancy.

Who cannot join

Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment;
Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, intrauterine device, s/p tubal ligation, or partner with vasectomy);
Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological or hematologic disease;
Lifetime history of seizure disorder;
Lifetime history or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of alcohol abuse within the last 12 months, which is permissible for MDD subjects); eating disorders, post-traumatic stress disorder (lifetime PTSD is exclusionary for control subjects, PTSD within the last 24 months is exclusionary for MDD subjects); simple phobia, social anxiety disorder and generalized anxiety disorders will be allowed only if secondary to MDD;
More than five instances of lifetime cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine);

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Use of dopaminergic drugs (including methylphenidate) within the last 6 months;
Lifetime history or current diagnosis of dementia, or a score of < 26 on the Mini Mental Status Examination at the screening visit;
Lifetime history of adverse drug reactions or allergy to the study drug (amisulpride);
Patients with mood congruent or mood incongruent psychotic features;
Current use of other psychotropic drugs;
Clinical or laboratory evidence of hypothyroidism;
Patients with a lifetime history of electroconvulsive therapy (ECT);
Patients with renal insufficiency;
Failure to meet standard MRI safety requirements
Electrolytes, blood urea nitrogen, creatinine: outside the normal range (also ruling out renal insufficiency);
Liver function tests above 1.5 times the upper normal;
Corrected QT interval (QTc) interval in EKG above 450 ms or EKG indicative of arrhythmia or cardiac conduction abnormalities;
Diabetes with poor glucose control;
Cardiac disease, bradycardia less than 55 bpm, hypokalemia, congenital prolongation of QT interval or on-going treatment with a medication likely to induce one of these conditions.
Currently in cognitive-behavioral therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

McLean Hospital
Belmont, Massachusetts, 02478

Other trials in United States

About this study

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.

Read the 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.

Conditions: Major Depressive Disorder (MDD)
Being tested: amisulpride, placebo
Keywords: MDD, Major Depressive Disorder, Amisulpride
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

amisulprideDrug
Also called Solian
single low-dose pharmacological challenge, 50 mg amisulpride
placeboDrug
single-dose placebo capsule

Study groups in NCT01253421
Study group	Role	What they receive
MDD-amisulpride	Active comparator	Subjects experiencing a current episode of major depression who are randomized to receive amisulpride Receives: Drug: amisulpride
MDD-placebo	Placebo comparator	Subjects experiencing a current episode of major depression who are randomized to receive placebo Receives: Drug: placebo
HC-amisulpride	Active comparator	Subjects having no history of mental disorder (healthy controls, HC) who are randomized to receive amisulpride Receives: Drug: amisulpride
HC-placebo	Placebo comparator	Subjects having no history of mental disorder who are randomized to receive placebo Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: administered after scan
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.
Measured: administered after scan
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.
Measured: Scan session
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.
Measured: Scan session
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.
Measured: Scan session
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.
Measured: During scan session
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.
Measured: During scan session
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.
Measured: During scan session

Secondary outcomes (2)

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
Measured: During scan session
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.
Measured: During scan session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012May 2016

First posted3 Dec 2010 (estimated)
Study startFeb 2012
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01253421
Sponsor's protocol ID: 2010-P001568
Other IDs: R01MH068376
Status last verified: Apr 2018
First submitted: 1 Dec 2010
Last updated: 27 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Admon R, Kaiser RH, Dillon DG, Beltzer M, Goer F, Olson DP, Vitaliano G, Pizzagalli DA. Dopaminergic Enhancement of Striatal Response to Reward in Major Depression. Am J Psychiatry. 2017 Apr 1;174(4):378-386. doi: 10.1176/appi.ajp.2016.16010111. Epub 2016 Oct 24.
PubMed 27771973
Liu Y, Admon R, Mellem MS, Belleau EL, Kaiser RH, Clegg R, Beltzer M, Goer F, Vitaliano G, Ahammad P, Pizzagalli DA. Machine Learning Identifies Large-Scale Reward-Related Activity Modulated by Dopaminergic Enhancement in Major Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Feb;5(2):163-172. doi: 10.1016/j.bpsc.2019.10.002. Epub 2019 Oct 22.
PubMed 31784354

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Dopamine on Reward Processing
ClinicalTrials.gov ID: NCT01253421
Acronym / sponsor ID: 2010-P001568
Conditions: Major Depressive Disorder (MDD)
Keywords: MDD, Major Depressive Disorder, Amisulpride
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Mclean HospitalUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Feb 2012
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 3 Dec 2010 (estimated)
Results: Posted 18 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypotheses:

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4
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.

Arm	Type	Receives
MDD-amisulpride	Active comparator	Drug: amisulprideSubjects experiencing a current episode of major depression who are randomized to receive amisulpride
MDD-placebo	Placebo comparator	Drug: placeboSubjects experiencing a current episode of major depression who are randomized to receive placebo
HC-amisulpride	Active comparator	Drug: amisulprideSubjects having no history of mental disorder (healthy controls, HC) who are randomized to receive amisulpride
HC-placebo	Placebo comparator	Drug: placeboSubjects having no history of mental disorder who are randomized to receive placebo

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (17 listed)

Inclusion Criteria for subjects with Major Depressive Disorder (MDD):
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);
Written informed consent;
Both genders and all ethnic origins, age between 18 and 45;
Right-handed;

Key exclusion criteria (21 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
amisulprideAlso: Soliansingle low-dose pharmacological challenge, 50 mg amisulpride	Drug	HC-amisulpride, MDD-amisulpride
placebosingle-dose placebo capsule	Drug	HC-placebo, MDD-placebo

Primary outcome

Effect on PST Reward Learning
Time frame: administered after scan
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.
Effect on PST Penalty Learning
Time frame: administered after scan
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.
Effect on Caudate Response to Cues
Time frame: Scan session
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.
Effect on NAcc Response to Cues
Time frame: Scan session
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.
Putamen Response to Cues
Time frame: Scan session
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.
Effect on Caudate Response to Reward
Time frame: During scan session
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.
Effect on NAcc Response to Reward
Time frame: During scan session
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.
Effect on Putamen Response to Reward
Time frame: During scan session
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.

2 secondary outcomes

Effect on Caudate-dACC Connectivity After Reward
Time frame: During scan session
Effect on NAcc-MCC Connectivity After Reward
Time frame: During scan session

Results and safety

Results posted to the registry on 18 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants Prior to Randomization	159	60
MDD-amisulpride	0	0
MDD-placebo	0	0
HC-amisulpride	0	0
HC-placebo	0	0

Primary outcome: Effect on PST Reward Learning

Time frame: administered after scan. Mean (Standard Deviation). Unit: Effect size (Beta)

Measure	MDD-amisulpride n = 14	MDD-placebo n = 12	HC-amisulpride n = 15	HC-placebo n = 11
Value	0.6271 (0.15608)	0.7575 (0.1676)	0.823 (0.1228)	0.7545 (0.1828)

Population analysed: Reward-learning results are missing for 7 subjects

Primary outcome: Effect on PST Penalty Learning

Time frame: administered after scan. Mean (Standard Deviation). Unit: Effect size (Beta)

Measure	MDD-amisulpride n = 14	MDD-placebo n = 12	HC-amisulpride n = 15	HC-placebo n = 11
Value	0.2428 (0.1800)	0.29 (0.2056)	0.2207 (0.20225)	0.2391 (0.14618)

Population analysed: Penalty-learning results are missing for 7 subjects

Primary outcome: Effect on Caudate Response to Cues

Time frame: Scan session. Mean (Standard Deviation). Unit: Effect size (Beta)

Measure	MDD-amisulpride n = 13	MDD-placebo n = 11	HC-amisulpride n = 16	HC-placebo n = 11
Value	0.2231 (0.42189)	-0.0391 (0.32792)	-0.0938 (0.57788)	0.0582 (0.30318)

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

Primary outcome: Effect on NAcc Response to Cues

Time frame: Scan session. Mean (Standard Deviation). Unit: Effect size (Beta)

Measure	MDD-amisulpride n = 13	MDD-placebo n = 11	HC-amisulpride n = 16	HC-placebo n = 11
Value	0.2446 (0.38546)	0.0736 (0.38694)	0.1356 (0.51800)	0.2182 (0.55236)

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Full study duration (2012-2015). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MDD-amisulpride	0 of 15 (0%)	0 of 15 (0%)	0 of 15
MDD-placebo	0 of 14 (0%)	0 of 14 (0%)	0 of 14
HC-amisulpride	0 of 16 (0%)	0 of 16 (0%)	0 of 16
HC-placebo	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): The choice of a 50-mg dose of amisulpride was based on animal work showing low doses potentiate striatal dopamine release, have strong hedonic effects, and increase the incentive value of environmental cues. Higher doses may have different results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27771973Admon R, Kaiser RH, Dillon DG, Beltzer M, Goer F, Olson DP, Vitaliano G, Pizzagalli DA. Dopaminergic Enhancement of Striatal Response to Reward in Major Depression. Am J Psychiatry. 2017 Apr 1;174(4):378-386. doi: 10.1176/appi.ajp.2016.16010111. Epub 2016 Oct 24.
Derived from this study: PubMed 31784354Liu Y, Admon R, Mellem MS, Belleau EL, Kaiser RH, Clegg R, Beltzer M, Goer F, Vitaliano G, Ahammad P, Pizzagalli DA. Machine Learning Identifies Large-Scale Reward-Related Activity Modulated by Dopaminergic Enhancement in Major Depression. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Feb;5(2):163-172. doi: 10.1016/j.bpsc.2019.10.002. Epub 2019 Oct 22.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Diego A Pizzagalli, PhD principal investigator

McLean Hospital, Harvard University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing amisulpride in people with Major Depressive Disorder (MDD), run by Mclean Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on PST Reward Learning (time frame: administered after scan). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01253421, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.