Status:
COMPLETED
Naltrexone for Antipsychotic-Induced Weight Gain
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Detailed Description
Persons with severe mental illness (SMI) die, on average, 25 years earlier than the general population1. Most of this early mortality can be attributed to cardiovascular disease (CVD) and diabetes mel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2019
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01866098
Start Date
May 1 2013
End Date
April 7 2019
Last Update
October 1 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519