Naltrexone for Antipsychotic-Induced Weight Gain

Completed · Not applicable · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar Disorder, Severe Major Depression With Psychotic Features

In brief

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").

Key facts

Study ID: NCT01866098
Run by: Yale University
People needed: 144
Starts: 2013-05-01
Expected to finish: 2019-04-07
Last updated by the study team: 2021-10-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Connecticut Mental Health Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.