Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in Schizophrenia

• Status: Terminated
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of combining open-label extended release bupropion (flexible dosing up to 450mg target) and naltrexone (37.5mg) versus Bupropion and placebo along with a daily 500 calorie reduction diet recommendation for weight and health risk reduction in 40 overweight/obese individuals with schizophrenia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Bupropion; Naltrexone

Criteria

Inclusion Criteria

1. Age 18 to 75

2. Meet DSM-IV criteria for schizophrenia or schizoaffective disorder based on SCID interview (If bipolar-schizoaffective: need to be adequately stabilized on a mood stabilizer and show no mania history for the past one year, as confirmed by study psychiatrist and patient's clinician)

3. Body Mass Index (BMI) of 28 and over

4. On a stable dose of antipsychotic medication; i.e. at least one month with no dose change, and three months from an antipsychotic switch

5. Deemed to be symptomatically stable by the clinical staff in the last two months

6. Over 7% total body weight increase on antipsychotics for subjects within first year of illness

Exclusion Criteria

1. 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.) Note: All subjects will be screened for drugs, not only those suspected of opiate use.

2. A history of seizures in the past five years (confirmed through chart review and discussion with patient's clinician)

3. Meet DSM criteria for Bipolar Disorder

4. History of mania in the past one year (confirmed through chart review and discussion with patient's clinician)

5. Uncontrolled hypertension

6. Insulin dependent diabetes mellitus

7. Current history of dementia, mental retardation

8. Not capable of giving informed consent for participation in the study

9. Women who are pregnant or breast-feeding

10. Physical conditions affecting body weight (e.g. Cushing's disease, polycystic ovary syndrome)

11. Severe liver dysfunction, (serum aminotransferases greater than three times normal), acute infectious hepatitis, liver failure.

12. History of glaucoma.