Naltrexone for Antipsychotic-Induced Weight Gain

NCT01866098 | Completed Results DMC

• 2 other identifiers: 12070105071R01DK093924-01A1
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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").

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Bipolar Disorder; Severe Major Depression With Psychotic Features

Keywords

antipsychotic; severe mental illness; weight loss

Outcome Measures

Primary Outcomes (2)

• Change in Weight From Baseline

  Weight (kilograms; kg) will be measured at each assessment and change in weight will be determined at study endpoint.

  Baseline and 52 weeks

• Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline

  Body Mass Index will be calculated at each assessment and change over time will be assessed at endpoint.

  52 weeks

Secondary Outcomes (6)

• Changes in Fasting Glucose From Baseline

  Baseline and 52 weeks

• Changes in Glycosylated Hemoglobin (HbA1c) From Baseline

  Baseline and 52 weeks

• Changes in Insulin From Baseline

  Baseline and 52 weeks

• Changes in Total Cholesterol From Baseline

  Baseline and 52 weeks

• Changes in HDL From Baseline

  Baseline and 52 weeks

Study Arms (3)

Naltrexone 50mg

EXPERIMENTAL

Oral Naltrexone 50mg capsule taken once daily for 52 weeks

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

Oral placebo capsule taken once daily for 52 weeks

Drug: Placebo

Naltrexone 25mg

EXPERIMENTAL

Oral Naltrexone 25mg capsule taken once daily for 52 weeks

Drug: Naltrexone

Interventions

Naltrexone DRUG

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.

Also known as: Revia

Naltrexone 25mg; Naltrexone 50mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75
• Meet Diagnostic \& Statistical Manual - 4 (DSM-IV) criteria for schizophrenia, schizoaffective disorder, bipolar disorder, major depression, or another psychotic disorder based on Structured Clinical Interview for the DSM-IV (SCID) interview
• Body Mass Index (BMI) of 28 and over
• On a stable dose of antipsychotic medication; i.e. at least one month with no dose change, and three months from an antipsychotic switch
• Deemed to be symptomatically stable by the clinical staff in the last two months
• Over 7% total body weight increase on antipsychotics for subjects within first year of illness

You may not qualify if:

• Meet criteria for current opiate abuse or dependence (confirmed by positive urine drug screen for opiates or, if suspected by study doctor via patient history and or suspicion of occult opiate use, a naloxone challenge will be performed.)
• Current history of dementia, mental retardation
• Not capable of giving informed consent for participation in the study
• Women who are pregnant or breast-feeding
• Physical conditions affecting body weight (e.g. Cushing's disease, polycystic ovary syndrome) Diabetes Mellitus (defined as prescribed an anti-diabetic medication for diabetes or a hemoglobin A1c level \> 7 confirmed by primary care physician at screening)
• Severe liver dysfunction, (serum aminotransferases greater than three times normal), acute infectious hepatitis, liver failure.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• 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.

  PMID: 23805859 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Mental Disorders; Weight Loss

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Associate Professor of Psychiatry; Director, Psychosis Program, CMHC
• Organization: Connecticut Mental Health Center

cenk.tek@yale.edu

(203) 974-7500

Study Officials

• Cenk Tek, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: May 31, 2013
• Study Start: May 1, 2013
• Primary Completion: April 7, 2019
• Study Completion: April 7, 2019
• Last Updated: October 1, 2021
• Results First Posted: April 8, 2020

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)