ObesePhase 4NCT02736474
Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia
A Phase 4 study testing Naltrexone and Bupropion in people with Obese and Cigarette-smoking, run by Shanghai Mental Health Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obese, Cigarette-smoking, Schizophrenia
- What is being tested?
- Naltrexone and Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia
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.
Read the 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.
- Conditions
- Obese, Cigarette-smoking, Schizophrenia
- Being tested
- Naltrexone, Placebo Naltrexone, Bupropion, Placebo Bupropion
- Medical subject headings
- Obesity, Cigarette Smoking, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo BupropionDrug
Placebo Bupropion created and masked by the pharmacy to be used as a control.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone and Bupropion | Experimental | 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. Receives: Drug: Naltrexone; Drug: Bupropion |
| Placebo Naltrexone and Bupropion | Placebo comparator | 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. Receives: Drug: Placebo Naltrexone; Drug: Placebo Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weight at 24 Weeks
evaluate all participants' weight ，weight in kilograms
Measured: baseline and 24 weeks
Secondary outcomes (14)
Numbers of Participants Who Quit Smoking
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Waist Circumference
evaluate all participants' waist circumference，waist circumference in centimeters
Measured: 24 weeks
Change in Fasting Blood Glucose Levels
Measured: baseline and 24 weeks
Change in Fasting Insulin Levels
Measured: baseline and 24 weeks
Change in Glycosylated Hemoglobin
Measured: baseline and 24 weeks
Change in Fasting Triglycerides Levels
Measured: baseline and 24 weeks
Change in Fasting HDL Cholesterol Levels
Measured: baseline and 24 weeks
Change in Fasting LDL Cholesterol
Measured: baseline and 24 weeks
Change in Leptin
Measured: baseline and 24 weeks
Change in Ghrelin
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Principal investigator, DU, Jiang, Shanghai Mental Health Center
- Investigators
- Jiang Du, PhD, Principal investigator, Chief Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736474
- Sponsor's protocol ID
- MZhao-005
- Status last verified
- Sep 2021
- First submitted
- 23 Mar 2016
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29563871
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02736474
- Acronym / sponsor ID
- MZhao-005
- Conditions
- Obese, Cigarette-smoking, Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Posted 22 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone and Bupropion | Experimental | Drug: Naltrexone, Drug: BupropionNaltrexone 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 and Bupropion | Placebo comparator | Drug: Placebo Naltrexone, Drug: Placebo BupropionPlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone3 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 | Naltrexone and Bupropion |
| Placebo NaltrexonePlacebo Naltrexone created and masked by the pharmacy to be used as a control. | Drug | Placebo Naltrexone and Bupropion |
| Bupropion1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study. | Drug | Naltrexone and Bupropion |
| Placebo BupropionPlacebo Bupropion created and masked by the pharmacy to be used as a control. | Drug | Placebo Naltrexone and Bupropion |
Primary outcome
Change From Baseline in Weight at 24 Weeks
Time frame: baseline and 24 weeks
evaluate all participants' weight ，weight in kilograms
14 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
Time frame: baseline and 24 weeks
Depression Status Assessed by Self-rating Depression Scale（SDS）
Time frame: 24 weeks
Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS）
Time frame: 24 weeks
Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)
Time frame: 24 weeks
Waist Circumference
Time frame: 24 weeks
Change in Fasting Blood Glucose Levels
Time frame: baseline and 24 weeks
Change in Fasting Insulin Levels
Time frame: baseline and 24 weeks
Change in Glycosylated Hemoglobin
Time frame: baseline and 24 weeks
Change in Fasting Triglycerides Levels
Time frame: baseline and 24 weeks
Change in Fasting HDL Cholesterol Levels
Time frame: baseline and 24 weeks
Change in Fasting LDL Cholesterol
Time frame: baseline and 24 weeks
Change in Leptin
Time frame: baseline and 24 weeks
Change in Ghrelin
Time frame: baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29563871Lyu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Du, PhD principal investigator
Chief Physician
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone and Bupropion in people with Obese and Cigarette-smoking, run by Shanghai Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Weight at 24 Weeks (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02736474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.