Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia
Overview
- Phase
- Phase 4
- Intervention
- Naltrexone
- Conditions
- Obese
- Sponsor
- Shanghai Mental Health Center
- Enrollment
- 22
- Primary Endpoint
- Change From Baseline in Weight at 24 Weeks
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
This is a randomized, double-blind, and placebo-controlled study. Subjects with evaluation and confirmation that inclusion and exclusion criteria are met, will be treated with naltrexone sustained release 15mg once per day and bupropion sustained release 150mg once per day in the first two weeks, and naltrexone 25mg once per day and bupropion 300mg once per day during the rest of the study.The purpose of this research is to observe the efficacy of Naltrexone and Bupropion on weight loss and smoking cessation compared to placebo.
Investigators
DU, Jiang
Chief Physician
Shanghai Mental Health Center
Eligibility 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).
Arms & Interventions
Naltrexone and Bupropion
Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.
Intervention: Naltrexone
Naltrexone and Bupropion
Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.
Intervention: Bupropion
Placebo Naltrexone and Bupropion
Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.
Intervention: Placebo Naltrexone
Placebo Naltrexone and Bupropion
Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.
Intervention: Placebo Bupropion
Outcomes
Primary Outcomes
Change From Baseline in Weight at 24 Weeks
Time Frame: baseline and 24 weeks
evaluate all participants' weight ，weight in kilograms
Secondary Outcomes
- Change in Fasting Blood Glucose Levels(baseline and 24 weeks)
- Change in Glycosylated Hemoglobin(baseline and 24 weeks)
- Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS）(24 weeks)
- Change in Fasting Insulin Levels(baseline and 24 weeks)
- Depression Status Assessed by Self-rating Depression Scale（SDS）(24 weeks)
- Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)(24 weeks)
- Waist Circumference(24 weeks)
- Change in Fasting HDL Cholesterol Levels(baseline and 24 weeks)
- Numbers of Participants Who Quit Smoking(24 weeks)
- Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks(baseline and 24 weeks)
- Change in Fasting LDL Cholesterol(baseline and 24 weeks)
- Change in Ghrelin(baseline and 24 weeks)
- Change in Fasting Triglycerides Levels(baseline and 24 weeks)
- Change in Leptin(baseline and 24 weeks)