Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

Phase 4

Completed

• Conditions: Obese; Cigarette-smoking; Schizophrenia
• Interventions: Drug: Placebo Naltrexone; Drug: Naltrexone; Drug: Placebo Bupropion; Drug: Bupropion

• Registration Number: NCT02736474
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-13
• Study Start: 2016-05
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Results First Submitted: 2020-01-13
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-25
• Last Update Submitted: 2021-09-25
• Results First Posted: 2021-10-22
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Naltrexone and Bupropion	Placebo Naltrexone	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.
Placebo Naltrexone and Bupropion	Placebo 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.
Naltrexone and Bupropion	Naltrexone	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.
Naltrexone and Bupropion	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Weight at 24 Weeks	baseline and 24 weeks	evaluate all participants' weight ，weight in kilograms

Secondary Outcome Measures

Name	Time	Method
Numbers of Participants Who Quit Smoking	24 weeks
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	evaluate all participants' depression status by Self-Rating Anxiety Scale，which has a theoretical value range of 20-80. The SAS total score ranges, with the higher the score representing the higher level of severity of anxiety.
Change in Fasting Insulin Levels	baseline and 24 weeks
Depression Status Assessed by Self-rating Depression Scale（SDS）	24 weeks	evaluate all participants' depression status by Self-rating depression scale（SDS)，which has a theoretical value range of 20-80. The SDS total score ranges, with the higher the score representing the higher level of severity of depression.
Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)	24 weeks	Through a simple 40 to 50 minute talk with the patient, the physician scored 30 different symptoms on a scale of 1-7 to get their PANSS score. The total score range from 30-210. The PANSS total score ranges, with the higher the score representing the higher level of severity of clinical symptoms.
Waist Circumference	24 weeks	evaluate all participants' waist circumference，waist circumference in centimeters
Change in Fasting HDL Cholesterol Levels	baseline and 24 weeks
Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks	baseline and 24 weeks	The visual analogue scale is a scale that is used to gauge smoking craving. Patients can choose a number from 0 to 10 to show their smoking craving, in which "0" represents "no craving" and "10" represents "intense urge".
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