Targeting Cognition in Bipolar Disorder With Pramipexole

• Status: Completed
• Trial end date: 2018-07-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital; Icahn School of Medicine at Mount Sinai
• Collaborators: Icahn School of Medicine at Mount Sinai; National Institute of Mental Health (NIMH); Northwell Health; The Zucker Hillside Hospital
• Treatments: Pramipexole

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