Cognitive Enhancement in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: pramipexole
Intervention description: po pramipexole versus matching placebo minimum 0.125 mg bid and maximum 0.75 mg bid
Intervention MeSH terms: Pramipexole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine whether the medication pramipexole (Mirapex) may be
      able to improve cognitive problems (i.e. difficulties with thinking, memory, and
      concentration) that may be associated with bipolar disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 18 and 65 years of age, who meet Diagnostic and Statistical Manual of
             Mental Disorders, 4th edition (DSM-IV) criteria for BPD I or II (by SCID) and
             confirmed in the diagnostic consensus conference will be included.

          -  Subjects must also meet criteria for euthymia described above.

          -  All subjects must be taking a standard mood stabilizer at a stable therapeutic dose
             (i.e. lithium, carbamazepine, valproate, lamotrigine).

        Exclusion Criteria:

          -  Subjects with a history of central nervous system (CNS) trauma, neurological disorder,
             Attention Deficit Hyperactivity Disorder (ADHD), or learning disability will be
             excluded.

          -  Subjects with a DSM-IV diagnosis of current or recent substance abuse or dependence
             (in the previous 1 month) will be excluded.

          -  Moreover, subjects with rapid-cycling during the past year will be excluded (based on
             SCID).

          -  Any subject with an active, unstable medical problem that may interfere with cognition
             will be excluded based on the investigator's judgment.

          -  While medication status is an important consideration in any study of bipolar
             disorder, the exclusion of patients taking any medication is not practical, given the
             high prevalence of combination pharmacotherapy for bipolar disorder. To help control
             for medication effects on cognition, we plan to limit the types of medications allowed
             by excluding certain medications with a known impact on cognitive performance.

               -  Subjects taking clozapine will be excluded due to it's potential overlapping
                  mechanisms of action with pramipexole.

               -  Subjects taking prescription or over-the counter medications may also be excluded
                  if these medications have been shown to impact cognition (i.e. diphenhydramine).

               -  The use of benzodiazepines, sedatives, or sleeping pills, within 6 hours of
                  neurocognitive testing will not be allowed. In addition, patients taking
                  topiramate, tricyclic antidepressants, or anticholinergic medications that are
                  known to impact cognition will be excluded from participation.

               -  Subjects taking any medications that are known to interact with pramipexole (i.e.
                  Zantac, Tagamet, Reglan, Benemid, Probalan, Compazine, Phenergan, quinidine,
                  selegiline, verapamil, and any other medication with a known interaction) will
                  also be excluded.