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Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

Primary Purpose

Obese, Cigarette-smoking, Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Naltrexone
Placebo Naltrexone
Bupropion
Placebo Bupropion
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Naltrexone and Bupropion

    Placebo Naltrexone and Bupropion

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Weight at 24 Weeks
    evaluate all participants' weight ，weight in kilograms

    Secondary Outcome Measures

    Numbers of Participants Who Quit Smoking
    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".
    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.
    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.
    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.
    Waist Circumference
    evaluate all participants' waist circumference，waist circumference in centimeters
    Change in Fasting Blood Glucose Levels
    Change in Fasting Insulin Levels
    Change in Glycosylated Hemoglobin
    Change in Fasting Triglycerides Levels
    Change in Fasting HDL Cholesterol Levels
    Change in Fasting LDL Cholesterol
    Change in Leptin
    Change in Ghrelin

    Full Information

    First Posted
    March 23, 2016
    Last Updated
    September 25, 2021
    Sponsor
    Shanghai Mental Health Center
    Collaborators
    University of Massachusetts, Worcester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02736474
    Brief Title
    Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia
    Official Title
    Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (Actual)
    Primary Completion Date
    July 2018 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Mental Health Center
    Collaborators
    University of Massachusetts, Worcester

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obese, Cigarette-smoking, Schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Naltrexone and Bupropion
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo Naltrexone and Bupropion
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    Naltrexone
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Naltrexone
    Intervention Description
    Placebo Naltrexone created and masked by the pharmacy to be used as a control.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupropion
    Intervention Description
    1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Bupropion
    Intervention Description
    Placebo Bupropion created and masked by the pharmacy to be used as a control.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Weight at 24 Weeks
    Description
    evaluate all participants' weight ，weight in kilograms
    Time Frame
    baseline and 24 weeks
    Secondary Outcome Measure Information:
    Title
    Numbers of Participants Who Quit Smoking
    Time Frame
    24 weeks
    Title
    Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks
    Description
    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
    Title
    Depression Status Assessed by Self-rating Depression Scale（SDS）
    Description
    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
    Title
    Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS）
    Description
    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
    Title
    Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)
    Description
    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
    Title
    Waist Circumference
    Description
    evaluate all participants' waist circumference，waist circumference in centimeters
    Time Frame
    24 weeks
    Title
    Change in Fasting Blood Glucose Levels
    Time Frame
    baseline and 24 weeks
    Title
    Change in Fasting Insulin Levels
    Time Frame
    baseline and 24 weeks
    Title
    Change in Glycosylated Hemoglobin
    Time Frame
    baseline and 24 weeks
    Title
    Change in Fasting Triglycerides Levels
    Time Frame
    baseline and 24 weeks
    Title
    Change in Fasting HDL Cholesterol Levels
    Time Frame
    baseline and 24 weeks
    Title
    Change in Fasting LDL Cholesterol
    Time Frame
    baseline and 24 weeks
    Title
    Change in Leptin
    Time Frame
    baseline and 24 weeks
    Title
    Change in Ghrelin
    Time Frame
    baseline and 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiang Du, PhD
    Organizational Affiliation
    Chief Physician
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29563871
    Citation
    Lyu X, Du J, Zhan G, Wu Y, Su H, Zhu Y, Jarskog F, Zhao M, Fan X. Naltrexone and Bupropion Combination Treatment for Smoking Cessation and Weight Loss in Patients With Schizophrenia. Front Pharmacol. 2018 Mar 5;9:181. doi: 10.3389/fphar.2018.00181. eCollection 2018.
    Results Reference
    derived

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    Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

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