Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

Shanghai Mental Health Center22 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obese Cigarette-smoking Schizophrenia

Interventions

NaltrexoneDRUG

3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.

Placebo NaltrexoneDRUG

Placebo Naltrexone created and masked by the pharmacy to be used as a control.

BupropionDRUG

1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Change From Baseline in Weight at 24 Weeks

evaluate all participants' weight ，weight in kilograms

Time frame: baseline and 24 weeks

Secondary Outcomes

Numbers of Participants Who Quit Smoking

Time frame: 24 weeks

Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 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".

Time frame: baseline and 24 weeks

Depression Status Assessed by Self-rating Depression Scale（SDS）

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.

Time frame: 24 weeks

Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS）

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.

Time frame: 24 weeks

Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)

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.

Time frame: 24 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.