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Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT02736474
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
DU, Jiang, 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.

Condition or disease Intervention/treatment Phase
Obese Cigarette-smoking Schizophrenia Drug: Naltrexone Drug: Placebo Naltrexone Drug: Bupropion Drug: Placebo Bupropion Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia
Actual Study Start Date : May 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Naltrexone
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.

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

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

Drug: Placebo Bupropion
Placebo Bupropion created and masked by the pharmacy to be used as a control.




Primary Outcome Measures :
  1. Change from baseline in weight at 24 weeks [ Time Frame: Baseline, 24 weeks ]
    evaluate all participants' weight ,weight in kilograms


Secondary Outcome Measures :
  1. Numbers of participants who quit smoking [ Time Frame: 24 weeks ]
    evaluate all participants' smoking statues by Exhale carbon monoxide concentrations in part per million。

  2. Changes from Baseline Craving for nicotine assessed by Visual Analog Scales (VAS) at 24 weeks [ Time Frame: Baseline, 24 weeks ]
    evaluate all participants' craving for nicotine by Visual Analog Scales (VAS)

  3. Depression status assessed by Self-rating depression scale(SDS) [ Time Frame: Baseline,2,4,12,and 24 weeks ]
    evaluate all participants' depression status by Self-rating depression scale(SDS)

  4. Anxiety status assessed by Self-Rating Anxiety Scale(SAS) [ Time Frame: Baseline,2,4,12,and 24 weeks ]
    evaluate all participants' depression status by Self-Rating Anxiety Scale(SAS)

  5. Clinical symptoms assessed by the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline,2,4,12,and 24 weeks ]
    evaluate all participants' Clinical symptoms by the Positive and Negative Syndrome Scale (PANSS)

  6. Clinical symptoms assessed by clinical global impressions scale(CGI) [ Time Frame: Baseline,2,4,12,and 24 weeks ]
    evaluate all participants' Clinical symptoms by clinical global impressions scale(CGI)

  7. Change from baseline in waist circumference at 24 weeks [ Time Frame: Baseline, 24 weeks ]
    evaluate all participants' waist circumference,waist circumference in centimeters

  8. Change in Fasting Blood Glucose Levels [ Time Frame: Baseline,12 and 24 weeks ]
  9. Change in Fasting Insulin Levels [ Time Frame: Baseline,12 and 24 weeks ]
  10. Change in glycosylated hemoglobin [ Time Frame: Baseline,12 and 24 weeks ]
  11. Change in Fasting Triglycerides Levels [ Time Frame: Baseline,12 and 24 weeks ]
  12. Change in Fasting HDL Cholesterol Levels [ Time Frame: Baseline,12 and 24 weeks ]
  13. Change in Homeostasis Model Assessment-Insulin Resistance Levels [ Time Frame: Baseline,12 and 24 weeks ]
  14. Change in Fasting LDL Cholesterol [ Time Frame: Baseline,12 and 24 weeks ]
  15. Change in leptin [ Time Frame: Baseline,12 and 24 weeks ]
  16. Change in ghrelin [ Time Frame: Baseline,12 and 24 weeks ]
  17. Resting state functional connectivity of the brain reward circuits on weight loss and smoking cessation [ Time Frame: Baseline,24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736474


Sponsors and Collaborators
Shanghai Mental Health Center
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Jiang Du, PhD Chief Physician

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DU, Jiang, Chief Physician, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT02736474     History of Changes
Other Study ID Numbers: MZhao-005
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bupropion hydrochloride, naltrexone hydrochoride drug combination
Naltrexone
Bupropion
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Obesity Agents