Double-blind, placebo-controlled trial of pioglitazone for bipolar depression

JOURNAL OF AFFECTIVE DISORDERS

卷:245

Article

Aftab, Awais¹  Kemp, David E.²  Ganocy, Stephen J.³  Schinagle, Martha³  Conroy, Carla³  Brownrigg, Brittany³  D'Arcangelo, Nicole³  Goto, Toyomi³  Woods, Nicole³  Serrano, Mary Beth³  Han, Huiqin³  Calabrese, Joseph R.³  Gao, Keming³ 

[1] Univ Calif San Diego, Dept Psychiat, 9500 Gilman Dr,MC0664, La Jolla, CA 92093 USA

[2] Advocate Hlth Care, 4440W 95th St, Oak Lawn, IL 60453 USA

[3] Case Western Reserve Univ, Dept Psychiat, Mood Disorders Program, Univ Hosp Cleveland,Med Ctr, 10524 Euclid Ave,12th Floor, Cleveland, OH 44106 USA

关键词: Pioglitazone;    Bipolar depression;    Leptin;    Insulin resistance;    Inflammatory markers;   

DOI  :  10.1016/j.jad.2018.11.090

来源: Elsevier

【 摘 要 】

Background: Objective of the present study was to conduct an 8-week double-blind, randomized, placebo-controlled trial to test the efficacy of pioglitazone in the treatment of bipolar depression. Methods: 38 outpatients with bipolar disorder and current major depressive episode were randomized to pioglitazone (15-45 mg/day) or placebo. The use of concomitant mood stabilizers, antipsychotics, and antidepressants was permitted. The primary outcome measure was the 30-item Inventory of Depressive Symptomatology, Clinician Rated (IDS-C30) total score change from baseline to endpoint. Laboratory evaluations, including serum level of inflammatory and metabolic biomarkers, were conducted. Results: 37 subjects were analyzed for efficacy (1 subject had no follow-up data). Mean reduction from baseline to week 8 in IDS-C30 score was -6.59 for pioglitazone and -11.63 for placebo. Mixed effects modeling indicated borderline statistically significant difference between the two groups (p = 0.056) in favor of placebo. On analysis of inflammatory and metabolic markers, a statistically significant negative correlation was noted between change in leptin levels and change in depression scores in the pioglitazone group (r=-0.61, p = 0.047) but not in the placebo group, the significance of which is unclear as the study failed to demonstrate antidepressant efficacy of pioglitazone over placebo. No serious adverse effects were reported, and pioglitazone was well-tolerated. Limitations: small sample size with inadequate power, concomitant use of other psychotropic medications, and lack of statistical adjustment for multiple testing. Conclusion: Current study does not support the antidepressant efficacy of pioglitazone in the treatment of bipolar depression. (240 words)

【 授权许可】

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