CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
Naltrexone +1 moredrug
Likely dose
Naltrexone 50mgfrom 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/NCT01866098
NCT01866098N/ACompleted
CompareCT.gov

Naltrexone for Antipsychotic-Induced Weight Gain

Yale University·interventional·Posted May 31, 2013·Updated Oct 1, 2021

In Brief

A clinical study evaluating Naltrexone and Placebo for Schizophrenia and 4 related conditions. Completed, enrolled 144 participants across 1 site.

Detailed 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").

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar Disorder, Severe Major Depression With Psychotic Features
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 31, 2013
Enrollment StartMay 1, 2013
Primary CompletionApr 7, 2019
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 13.1 years ago

Interventions

Naltrexonedrug

25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.

Placebodrug