Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in Schizophrenia
Condition: Schizophrenia; Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus, Type 2; Weight Loss; Schizophrenia
Intervention: Naltrexone; Bupropion; Placebo
Intervention description: 37.mg oral capsule taken once daily for over the course of the study (16 weeks); Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.; Oral placebo taken once daily for the course of the study (16 week)
Intervention MeSH terms: Naltrexone; Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Naltrexone versus Placebo assignment will remain double-blinded for the duration of the study; Bupropion dosing will be open-label and not masked to either participant or investigator.
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Schizophrenia; Diabetes; Obesity

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.
    

Eligibility 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.