Imaging the Nucleus Accumbens in Major Depressed Patients 'Treated With Pramipexole
Condition: Depression
MeSH terms: Depression
Intervention: Pramipexole
Intervention description: Patients will received increasing dose of pramipexole
Intervention MeSH terms: Pramipexole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      We hope to learn how a brain circuit that is important to the understanding of depression,
      anhedonia and positive affect responds to a novel pharmaceutical treatment for depression and
      related symptoms. Adults who have a diagnosis of major depression and are not completely
      responsive to antidepressant medication will be sought out for participation; as will an
      equal number of adults not suffering from the disorder. Those suffering from depression will
      be given pramipexole, an investigational medication for eight weeks during which information
      will be collected about mood, cognition, and brain function. Adults not suffering from
      depression will also be evaluated with these measures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must meet DSM-IV criteria for Major Depressive Disorder

          2. HAM-D score >18 on a 21-item assessment at eligibility

          3. On at least an adequate dose of fluoxetine (40 mg/day), paroxetine (40 mg/day)
             paroxetine CR (50mg), sertraline (150 mg/day), citalopram (40 mg/day), escitalopram
             (20 mg/day), venlafaxine (150 mg/day), mirtazapine (30 mg/day), or duloxetine (60
             mg/day) for at least 6 weeks (monotherapy).

          4. 20-55 years of age

        Exclusion Criteria:

          1. Substance abuse in the past 6 months

          2. ECT in the past 6 months

          3. On a MAOI, tricyclic antidepressant, lithium, an antipsychotic, thyroid augmentation,
             2 antidepressants simultaneously or lamotrigine

          4. History of any psychosis including psychotic depression

          5. History of Bipolar I, Bipolar II, or Bipolar NOS illness, or concurrent symptoms of
             mania or hypomania that do not meet the criteria for any bipolar disorder

          6. History of compulsive gambling

          7. Pregnant females or females of childbearing years not using adequate birth control in
             the opinion of the investigators

          8. Known sensitivity to Pramipexole

          9. Significant suicide risk in the opinion of the investigators

         10. Significant medical conditions that would preclude safe participation in the study in
             the opinion of the investigators

         11. Psychoactive drugs other than one of the antidepressants listed on Inclusion criteria
             #4. (A non-barbiturate sedative or hypnotic or benzodiazepine such as trazodone
             50mg/day, zolpidem 10mg/day, lorazepam 3mg/day or clonazepam 2mg/day will be allowed
             if it has been in use for at least 1 month prior to the baseline visit.)

         12. Significant abnormalities are observed in screening laboratory evaluation.