Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to observe the efficacy of Naltrexone and Bupropion combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Mental Health Center
• Collaborator: University of Massachusetts, Worcester
• Treatments: Bupropion; Bupropion hydrochloride, naltrexone hydrochoride drug combination; Naltrexone

Criteria

Inclusion Criteria:

• diagnosis of schizophrenia by the International Classification of Diseases 10th Revision (ICD-10);

• age between 18 and 65 years old;

• on stable antipsychotic medication treatment for at least one month;

• BMI > 28 kg/m2 according to BMI criterion for obesity in the Chinese population ， or BMI>27 kg/m2 in the presence of dyslipidemia, or male with waist circumference over 90cm;

• smoking at least 10 cigarettes daily for one year or longer;

• desire to lose weight and quit smoking.

Exclusion Criteria:

• Binge eating or other eating disorders;

• Current use of weight loss or antidiabetic medications;

• Current substance use (except nicotine or caffeine);

• Elevated hepatic transaminase levels (>2.5x normal range);

• Clinically significant Thyroid Stimulating Hormone（TSH） and/or thyroxine4（T4） abnormalities;

• History of seizure disorder;

• History of unstable cardiac problems or other unstable medication conditions;

• Being pregnant or nursing (for women).