Naltrexone for Antipsychotic-Induced Weight Gain

• Status: Completed
• Trial end date: 2019-04-07
• Target enrollment: 0
• Participant gender: All

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").

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Antipsychotic Agents; Naltrexone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.