Pioglitazone for the Treatment of Bipolar Depression

Phase 4 Terminated 37 enrolled University Hospitals Cleveland Medical Center The Depressive and Bipolar Disorder Alternative Treatment Foundation · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective is to test the hypothesis that adjunctive pioglitazone is more effective than placebo for the relief of acute depressive symptoms resulting from bipolar disorder. The secondary objectives are to determine potential moderators and mediators of antidepressant efficacy.

Timeline

Start: 2012-09
Primary completion: 2016-03
Completion: 2016-03

Outcome

Missed primary endpoint

Stopped: “The study ended early due to budgetary issues”

paper Mixed effects modeling indicated borderline statistically significant difference between the two groups (p = 0.056) in favor of placebo. PMID 30699881 ↗

paper the study failed to demonstrate antidepressant efficacy of pioglitazone over placebo. PMID 30699881 ↗

Publications

Aftab A, Kemp DE, Ganocy SJ, Schinagle M, Conroy C, Brownrigg B, D'Arcangelo N, Goto T, Woods N, Serrano MB, Han H, Calabrese JR, Gao K. Double-blind, placebo-controlled trial of pioglitazone for bipolar depression. J Affect Disord. 2019 Feb 15;245:957-964. doi: 10.1016/j.jad.2018.11.090. Epub 2018 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pioglitazone	Small molecule	45 mg	—