The Effects of Dopamine on Reward Processing

This study is currently recruiting participants.
Verified October 2013 by Mclean Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Diego A. Pizzagalli, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01253421
First received: December 1, 2010
Last updated: October 31, 2013
Last verified: October 2013

December 1, 2010
October 31, 2013
February 2012
January 2015   (final data collection date for primary outcome measure)
  • Performance on a behavioral task assessing learning from positive and negative feedback. [ Time Frame: one-time task, administered during session 2 ] [ Designated as safety issue: No ]
  • Brain activation during a task involving monetary rewards. [ Time Frame: one-time task, administered at session 2 ] [ Designated as safety issue: No ]
  • Brain activation to social positive and negative feedback [ Time Frame: second session ] [ Designated as safety issue: No ]
    Brain activation to social positive and negative feedback
Same as current
Complete list of historical versions of study NCT01253421 on ClinicalTrials.gov Archive Site
Ratings of mood and affect. [ Time Frame: administered at sessions 1 and 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Dopamine on Reward Processing
The Effects of Dopamine on Reward Processing

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.

Through an integration of an 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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder (MDD)
  • Drug: Amisulpride
    single low-dose pharmacological challenge, 50 mg amisulpride
    Other Name: Solian
  • Drug: Placebo
    single-dose placebo capsule
  • Active Comparator: Amisulpride
    single low-dose pharmacological challenge, 50 mg amisulpride capsule
    Intervention: Drug: Amisulpride
  • Placebo Comparator: Placebo
    single-dose placebo capsule
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Inclusion Criteria for MDD Subjects:

    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 HRSD score > 16 (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:

  • Exclusion Criteria for All Subjects:

    1. Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment;
    2. 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, IUD, s/p tubal ligation, or partner with vasectomy);
    3. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological or hematologic disease;
    4. Lifetime history of seizure disorder;
    5. 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 cocaine or stimulant abuse; which will lead to exclusion); simple phobia, social anxiety disorder and generalized anxiety disorders will be allowed only if secondary to MDD;
    6. Lifetime history of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine);
    7. Lifetime history of use of dopaminergic drugs (including methylphenidate);
    8. Lifetime history or current diagnosis of dementia, or a score of < 26 on the Mini Mental Status Examination at the screening visit;
    9. Lifetime history of adverse drug reactions or allergy to the study drug (amisulpride);
    10. Patients with mood congruent or mood incongruent psychotic features;
    11. Current use of other psychotropic drugs;
    12. Clinical or laboratory evidence of hypothyroidism;
    13. Patients with a lifetime history of electroconvulsive therapy (ECT);
    14. Patients with renal insufficiency;
    15. Failure to meet standard MRI safety requirements
    16. Electrolytes, BUN, Creatinine: outside the normal range (also ruling out renal insufficiency);
    17. Liver function tests (SGOT, SGPT, CPK, alkaline phosphatase, total bilirubin) above 1.5X upper normal;
    18. QTc interval in EKG above 450 ms or EKG indicative of arrhythmia or cardiac conduction abnormalities;
    19. Diabetes with poor glucose control;
    20. 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.
Both
18 Years to 45 Years
Yes
Contact: Laura M Murray, BA 617-855-4236 lmurray@mclean.harvard.edu
Contact: Andrew L Cohen, BS 617-855-4237 acohen@mclean.harvard.edu
United States
 
NCT01253421
2010-P001568, R01MH068376
No
Diego A. Pizzagalli, Mclean Hospital
Mclean Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Diego A Pizzagalli, PhD McLean Hospital, Harvard University
Mclean Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP