Targeting Cognition in Bipolar Disorder With Pramipexole
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Pramipexole; Placebo
Intervention description: Up to 4.5mg, PO, (by mouth) per day of the 12-week study.; placebo match study drug
Intervention MeSH terms: Pramipexole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Cognition

Summary:

      Converging evidence suggests that patients with bipolar disorder suffer from deficits in
      neurocognitive functioning that persist, despite remission of acute affective symptoms. These
      impairments contribute directly to functional disability, highlighting the need for
      interventions above and beyond standard treatments in order to achieve a full inter-episode
      recovery. The current study aims to investigate the safety and efficacy of a dopamine agonist
      (pramipexole), on these persistent cognitive abnormalities in euthymic bipolar patients using
      a placebo-controlled, adjunctive, 12-week trial design.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age 18-65

          -  DSM-IV BD I or II diagnosis

          -  Affective stability, defined by a Young Mania Rating Scale (YMRS) rating of < 8 and a
             Hamilton Depression Rating Scale (HRSD) rating of < 16 at screening and baseline. We
             will further require that any subsyndromal depression has not significantly worsened
             in the 4 weeks prior to randomization so as to avoid enrolling subjects who are on the
             verge of a full depressive episode.

          -  Evidence of clinically-significant neurocognitive impairment at screening

          -  Clinically-acceptable, stably-dosed, mood stabilizing medication regimen for > 1 month
             prior to enrollment, with no medication changes planned over the 12-week study period.

        Exclusion Criteria:

          -  History of CNS trauma, neurological disorder, ADHD, or learning disability

          -  Positive urine toxicology or DSM-IV diagnosis of substance abuse/dependence within 3
             months

          -  Active, unstable medical problem that may interfere with cognition

          -  Recent history of rapid-cycling

          -  Abnormal lab or ECG result at screen

          -  History of heart failure

          -  Significant suicidal risk (HRSD item 3 > 2 or by clinical judgment)

          -  Estimated IQ in MR range as per Wide Range Achievement Test (WRAT) standard score of
             less than 70

          -  Pregnant women or women of child bearing potential who are not using a medically
             accepted means of contraception (including oral contraceptive or implant, condom,
             diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)

          -  Women who are breastfeeding

          -  Participation in any other investigational cognitive enhancement study within 30 days