Trial Outcomes & Findings for Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia (NCT NCT02736474)

NCT ID: NCT02736474

Last Updated: 2021-10-22

Results Overview

evaluate all participants' weight ，weight in kilograms

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 22 participants
• Primary outcome timeframe: baseline and 24 weeks
• Results posted on: 2021-10-22

Participant Flow

Participant milestones

Measure	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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Overall Study STARTED	11	11
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

Baseline characteristics by cohort

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=11 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.	Total n=22 Participants Total of all reporting groups
Age, Continuous	54.3 years STANDARD_DEVIATION 5.7 • n=5 Participants	54.1 years STANDARD_DEVIATION 8.4 • n=7 Participants	54.2 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex/Gender, Customized male	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Han	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment China	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
illness time duration	29.8 years STANDARD_DEVIATION 4.6 • n=5 Participants	25.9 years STANDARD_DEVIATION 9.1 • n=7 Participants	27.9 years STANDARD_DEVIATION 7.8 • n=5 Participants
smoking time duration	28.6 years STANDARD_DEVIATION 7.9 • n=5 Participants	29.8 years STANDARD_DEVIATION 9.8 • n=7 Participants	29.2 years STANDARD_DEVIATION 8.7 • n=5 Participants
breath CO level	27.1 ppm STANDARD_DEVIATION 23.2 • n=5 Participants	27.7 ppm STANDARD_DEVIATION 15.6 • n=7 Participants	27.4 ppm STANDARD_DEVIATION 19.3 • n=5 Participants
number of cigarettes smoked per week	72.5 cigarettes per week STANDARD_DEVIATION 5.7 • n=5 Participants	77.6 cigarettes per week STANDARD_DEVIATION 21.1 • n=7 Participants	75.1 cigarettes per week STANDARD_DEVIATION 15.3 • n=5 Participants
smoking craving	6.3 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants	7.0 units on a scale STANDARD_DEVIATION 1.4 • n=7 Participants	6.6 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants
body weight	74.7 kg STANDARD_DEVIATION 11.8 • n=5 Participants	80.2 kg STANDARD_DEVIATION 11.8 • n=7 Participants	77.5 kg STANDARD_DEVIATION 10.4 • n=5 Participants
BMI	26.8 kg/m^2 STANDARD_DEVIATION 2.0 • n=5 Participants	28.5 kg/m^2 STANDARD_DEVIATION 3.7 • n=7 Participants	27.6 kg/m^2 STANDARD_DEVIATION 3.0 • n=5 Participants
waist circumference	94.9 cm STANDARD_DEVIATION 4.5 • n=5 Participants	99.8 cm STANDARD_DEVIATION 6.8 • n=7 Participants	97.4 cm STANDARD_DEVIATION 6.2 • n=5 Participants
HbA1c	6.1 percentage of HbA1c STANDARD_DEVIATION 0.6 • n=5 Participants	6.3 percentage of HbA1c STANDARD_DEVIATION 1.8 • n=7 Participants	6.2 percentage of HbA1c STANDARD_DEVIATION 1.2 • n=5 Participants
fasting glucose	5.5 mmol/l STANDARD_DEVIATION 1.1 • n=5 Participants	5.5 mmol/l STANDARD_DEVIATION 2.2 • n=7 Participants	5.5 mmol/l STANDARD_DEVIATION 1.7 • n=5 Participants
HDL	0.9 mmol/l STANDARD_DEVIATION 0.2 • n=5 Participants	0.8 mmol/l STANDARD_DEVIATION 0.1 • n=7 Participants	0.9 mmol/l STANDARD_DEVIATION 0.2 • n=5 Participants
LDL	2.8 mmol/l STANDARD_DEVIATION 0.8 • n=5 Participants	2.4 mmol/l STANDARD_DEVIATION 0.9 • n=7 Participants	2.6 mmol/l STANDARD_DEVIATION 0.8 • n=5 Participants
insulin	106.8 pmol/l STANDARD_DEVIATION 65.8 • n=5 Participants	84.5 pmol/l STANDARD_DEVIATION 60.4 • n=7 Participants	95.7 pmol/l STANDARD_DEVIATION 62.5 • n=5 Participants
Triglyceride	2.3 mmol/l STANDARD_DEVIATION 1.1 • n=5 Participants	1.5 mmol/l STANDARD_DEVIATION 0.6 • n=7 Participants	1.9 mmol/l STANDARD_DEVIATION 0.9 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 24 weeks

evaluate all participants' weight ，weight in kilograms

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Change From Baseline in Weight at 24 Weeks	0.2 kilogram Standard Deviation 5.3	-0.9 kilogram Standard Deviation 3.1

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Numbers of Participants Who Quit Smoking	0 participants	0 participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks	-1.0 score on a scale Standard Deviation 2.9	-1.9 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Depression Status Assessed by Self-rating Depression Scale（SDS）	39.4 score on a scale Standard Deviation 8.2	33.6 score on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS）	31.1 score on a scale Standard Deviation 6.9	28.8 score on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)	52.5 score on a scale Standard Deviation 15.0	57.2 score on a scale Standard Deviation 18.9

SECONDARY outcome

Timeframe: 24 weeks

evaluate all participants' waist circumference，waist circumference in centimeters

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Waist Circumference	98.6 cm Standard Deviation 5.7	101.3 cm Standard Deviation 6.6

SECONDARY outcome

Timeframe: baseline and 24 weeks

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Change in Fasting Blood Glucose Levels	0.5 mmol/l Standard Deviation 1.5	1.0 mmol/l Standard Deviation 1.6

SECONDARY outcome

Timeframe: baseline and 24 weeks

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Change in Fasting Insulin Levels	3.5 pmol/l Standard Deviation 74.4	11.0 pmol/l Standard Deviation 35.3

SECONDARY outcome

Timeframe: baseline and 24 weeks

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Change in Glycosylated Hemoglobin	0.05 percentage of hemoglobin Standard Deviation 0.6	0.4 percentage of hemoglobin Standard Deviation 1.1

SECONDARY outcome

Timeframe: baseline and 24 weeks

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Change in Fasting Triglycerides Levels	-1.0 mmol/l Standard Deviation 0.9	-0.4 mmol/l Standard Deviation 0.6

SECONDARY outcome

Timeframe: baseline and 24 weeks

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Change in Fasting HDL Cholesterol Levels	0.0 mmol/l Standard Deviation 1.1	0.0 mmol/l Standard Deviation 0.1

SECONDARY outcome

Timeframe: baseline and 24 weeks

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Change in Fasting LDL Cholesterol	-0.4 mmol/l Standard Deviation 0.7	-0.2 mmol/l Standard Deviation 0.7

SECONDARY outcome

Timeframe: baseline and 24 weeks

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Change in Leptin	9.2 ng/ml Standard Deviation 5.9	10.6 ng/ml Standard Deviation 7.1

SECONDARY outcome

Timeframe: baseline and 24 weeks

Outcome measures

Measure	Naltrexone and Bupropion n=11 Participants 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: 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. 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 Naltrexone and Bupropion n=10 Participants 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Change in Ghrelin	352.2 pg/ml Standard Deviation 296.6	254.8 pg/ml Standard Deviation 106.4

Adverse Events

Naltrexone and Bupropion

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Naltrexone and Bupropion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Naltrexone and Bupropion n=11 participants at risk 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: 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. 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 Naltrexone and Bupropion n=10 participants at risk 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: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Gastrointestinal disorders dry mouth	45.5% 5/11 • Number of events 5 • The 24-week study time period	0.00% 0/10 • The 24-week study time period
Gastrointestinal disorders mild abdominal discomfort	9.1% 1/11 • Number of events 1 • The 24-week study time period	0.00% 0/10 • The 24-week study time period
Cardiac disorders tachycardia	0.00% 0/11 • The 24-week study time period	10.0% 1/10 • Number of events 1 • The 24-week study time period

Additional Information

Chief Physician Dr Du. Jiang Du

Shanghai Mental Health Center

Phone: 86-21-64387250

Email: dujiangdou@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place