Naltrexone for Antipsychotic-Induced Weight Gain

Summary

This study is designed to look at the effects of naltrexone on weight loss in individuals treated with antipsychotic medications. Naltrexone is an FDA approved medication for the management of alcohol dependence and drug dependence, but has not been fully evaluated for its effect on weight loss in individuals with severe mental illness (i.e. schizophrenia, schizoaffective disorder, bipolar disorder etc.) The purpose of this study is to find out how effective two different doses of oral naltrexone is on reducing body weight when compared to placebo (an inactive substance or "sugar pill").

Timeline

Start

2013-05

Primary completion

2019-04-07

Completion

2019-04-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Naltrexone 25mg vs Naltrexone 50mg; p = 0.83; Mixed Models Analysis NCT01866098 ↗

registry analysis (superiority test); Placebo vs Naltrexone 25mg vs Naltrexone 50mg; p = 0.10; Chi-squared NCT01866098 ↗

Publications

• Tek C, Guloksuz S, Srihari VH, Reutenauer EL. Investigating the safety and efficacy of naltrexone for anti-psychotic induced weight gain in severe mental illness: study protocol of a double-blind, randomized, placebo-controlled trial. BMC Psychiatry. 2013 Jun 27;13:176. doi: 10.1186/1471-244X-13-176.

Drugs

Indications