Targeting Cognition in Bipolar Disorder With Pramipexole
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.
Timeline
- Start
- 2014-10
- Primary completion
- 2018-07-26
- Completion
- 2018-07-26
Outcome
Missed primary endpoint
registry analysis (other test); Pramipexole vs Placebo; p = 0.38; t-test, 2 sided NCT02397837 ↗
registry analysis (other test); Pramipexole vs Placebo; p = 0.22; t-test, 2 sided NCT02397837 ↗
registry analysis (other test); Pramipexole vs Placebo; p = 0.17; t-test, 2 sided NCT02397837 ↗
Publications
- Background Burdick KE, Braga RJ, Nnadi CU, Shaya Y, Stearns WH, Malhotra AK. Placebo-controlled adjunctive trial of pramipexole in patients with bipolar disorder: targeting cognitive dysfunction. J Clin Psychiatry. 2012 Jan;73(1):103-12. doi: 10.4088/JCP.11m07299. Epub 2011 Nov 29.
- Background Goldberg JF, Burdick KE, Endick CJ. Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression. Am J Psychiatry. 2004 Mar;161(3):564-6. doi: 10.1176/appi.ajp.161.3.564.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pramipexole | Unknown | 4.5 mg | Oral |