NCT01866098: NTX

Naltrexone for Antipsychotic-Induced Weight Gain

Completed NA Results posted Last updated 3 September 2021

What this trial tests

NA trial testing Naltrexone in Schizophrenia in 144 participants. Completed in 7 April 2019.

Timeline

1 May 2013

Primary endpoint
7 April 2019

7 April 2019

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	144
Start date	1 May 2013
Primary completion	7 April 2019
Estimated completion	7 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Naltrexone — full drug profile →
• Placebo

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizoaffective Disorder — all drugs for Schizoaffective Disorder →
• Schizophreniform Disorder — all drugs for Schizophreniform Disorder →
• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Yale University

Who can join

Adults 18 to 75, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Weight From Baseline
  Time frame: Baseline and 52 weeks
  Weight (kilograms; kg) will be measured at each assessment and change in weight will be determined at study endpoint.
• Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline
  Time frame: 52 weeks
  Body Mass Index will be calculated at each assessment and change over time will be assessed at endpoint.

Sponsor's own description

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").

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Tek C, Guloksuz S, Srihari VH, Reutenauer EL. · · 2013 · cited 14× · PMID 23805859 · DOI 10.1186/1471-244x-13-176