N/A Completed N=144 Randomized Quadruple-blind Treatment

Naltrexone for Antipsychotic-Induced Weight Gain

Schizophrenia · schizoaffective disorder · Schizophreniform Disorder · Bipolar Disorder

Source: ClinicalTrials.gov NCT01866098 ↗

Enrolled (actual)

144

Serious AEs

0.7%

Results posted

Apr 2020

Primary outcomePrimary: Change in Weight From Baseline — -0.16; 0.69; -0.95 kg — p=0.83

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").

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Weight From Baseline	-0.16; 0.69; -0.95	0.83
PRIMARY Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline	10; 4; 9	0.10
SECONDARY Changes in Fasting Glucose From Baseline	8.2; 4.6; -0.4	0.19
SECONDARY Changes in Glycosylated Hemoglobin (HbA1c) From Baseline	-0.007; -0.061; 0.060	0.96
SECONDARY Changes in Insulin From Baseline	6.45; 0.45; 2.16	0.92
SECONDARY Changes in Total Cholesterol From Baseline	-1.16; 1.52; -3.02	0.98
SECONDARY Changes in HDL From Baseline	0.04; 0.79; 0.36	0.95
SECONDARY Changes in LDL From Baseline	-10.87; 1.14; -4.40	0.43

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01866098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.