Trial Outcomes & Findings for Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in Schizophrenia (NCT NCT03132571)
NCT ID: NCT03132571
Last Updated: 2019-08-07
Results Overview
BMI will be calculated using weekly height and weight measurements (kg/m\^2) at each assessment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2019-08-07
Participant Flow
30 people were screened by telephone. 18/30 people screened were deemed ineligible. The reasons for ineligibility were: antidepressant medication use (11/18), a history of seizures (4/18) and already taking Naltrexone (3/18). 12/30 people were eligible, 6/12 were initially interested in the study and ultimately, only 5/6 were consented.
Participant milestones
| Measure |
Naltrexone With Bupropion
Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.
Naltrexone: 37.mg oral capsule taken once daily for over the course of the study (16 weeks)
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
|
Placebo With Bupropion
Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
Placebo: Oral placebo taken once daily for the course of the study (16 week)
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in Schizophrenia
Baseline characteristics by cohort
| Measure |
Naltrexone With Bupropion
n=3 Participants
Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.
Naltrexone: 37.mg oral capsule taken once daily for over the course of the study (16 weeks)
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
|
Placebo With Bupropion
n=2 Participants
Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
Placebo: Oral placebo taken once daily for the course of the study (16 week)
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.33 years
STANDARD_DEVIATION 8.14 • n=5 Participants
|
58.00 years
STANDARD_DEVIATION 1.41 • n=7 Participants
|
51.00 years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Presented are the baseline and 16 weeks summary data on the 5 patients enrolled.
BMI will be calculated using weekly height and weight measurements (kg/m\^2) at each assessment.
Outcome measures
| Measure |
Naltrexone With Bupropion
n=3 Participants
Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.
Naltrexone: 37.mg oral capsule taken once daily for over the course of the study (16 weeks)
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
|
Placebo With Bupropion
n=2 Participants
Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
Placebo: Oral placebo taken once daily for the course of the study (16 week)
|
|---|---|---|
|
BMI
Baseline
|
39.06 kg/m^2
Standard Deviation 6.03
|
29.55 kg/m^2
Standard Deviation 0.07
|
|
BMI
16 Weeks
|
37.33 kg/m^2
Standard Deviation 5.81
|
30.65 kg/m^2
Standard Deviation 3.88
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Presented are the baseline and 16 weeks summary data on the 5 patients enrolled.
Weight in kilograms will be measured at each assessment and change will be determined at study endpoint.
Outcome measures
| Measure |
Naltrexone With Bupropion
n=3 Participants
Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.
Naltrexone: 37.mg oral capsule taken once daily for over the course of the study (16 weeks)
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
|
Placebo With Bupropion
n=2 Participants
Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
Placebo: Oral placebo taken once daily for the course of the study (16 week)
|
|---|---|---|
|
Weight (kg)
Baseline
|
118.78 kg
Standard Deviation 11.17
|
87.25 kg
Standard Deviation 15.48
|
|
Weight (kg)
16 Weeks
|
113.60 kg
Standard Deviation 11.24
|
91.25 kg
Standard Deviation 27.64
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: These labratory data were not collected and summarized due to the removal of diabetes from the study criteria and the early termination of the study.
Serum lipid profiles, fasting glucose, and glycosylated hemoglobin (hbA1c) will be measured at baseline and week 16 and change in these markers will be determined at endpoint
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Presented are the baseline and 16 weeks summary data on the 5 patients enrolled.
Waist circumference will be measured in inches at each assessment.
Outcome measures
| Measure |
Naltrexone With Bupropion
n=3 Participants
Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.
Naltrexone: 37.mg oral capsule taken once daily for over the course of the study (16 weeks)
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
|
Placebo With Bupropion
n=2 Participants
Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
Placebo: Oral placebo taken once daily for the course of the study (16 week)
|
|---|---|---|
|
Waist Circumference (Inches)
16 Weeks
|
48.50 inches
Standard Deviation 5.76
|
43.37 inches
Standard Deviation 2.29
|
|
Waist Circumference (Inches)
Baseline
|
50.08 inches
Standard Deviation 5.26
|
41.87 inches
Standard Deviation 1.23
|
Adverse Events
Naltrexone With Bupropion
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo With Bupropion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone With Bupropion
n=3 participants at risk
Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.
Naltrexone: 37.mg oral capsule taken once daily for over the course of the study (16 weeks)
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
|
Placebo With Bupropion
n=2 participants at risk
Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.
Bupropion: Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
Placebo: Oral placebo taken once daily for the course of the study (16 week)
|
|---|---|---|
|
General disorders
Nausea
|
66.7%
2/3 • Adverse events were monitored in patients up to 16 weeks post randomization.
|
0.00%
0/2 • Adverse events were monitored in patients up to 16 weeks post randomization.
|
Additional Information
Dr. Cenk Tek
Yale School of Medicine, Department of Psychiatry
Phone: (203) 974-7500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place