CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 103 enrolled
Drug / intervention
Pramipexole +1 moredrug
Likely dose
Pramipexole 4.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02397837
NCT02397837Phase 4Completed
CompareCT.gov

Pramipexole in Bipolar Disorder: Targeting Cognition (PRAM-BD)

Brigham and Women's Hospital·interventional·Posted Mar 25, 2015·Updated Feb 28, 2020

In Brief

A Phase 4 clinical trial evaluating Pramipexole and Placebo for Bipolar Disorder. Completed, enrolled 103 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsThe Zucker Hillside Hospital, Northwell Health, National Institute of Mental Health (NIMH), Icahn School of Medicine at Mount Sinai

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 25, 2015
Enrollment StartOct 1, 2014
Primary CompletionJul 26, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.3 years ago

Interventions

Pramipexoledrug

Up to 4.5mg, PO, (by mouth) per day of the 12-week study.

Placebodrug

placebo match study drug