| Trial ID: | L6562 |
| Source ID: | NCT03132571
|
| Associated Drug: |
Naltrexone
|
| Title: |
Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in Schizophrenia
|
| Acronym: |
NBC
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03132571/results
|
| Conditions: |
Schizophrenia|Diabetes Mellitus, Type 2|Obesity
|
| Interventions: |
DRUG: Naltrexone|DRUG: Bupropion|OTHER: Placebo
|
| Outcome Measures: |
Primary: BMI, BMI will be calculated using weekly height and weight measurements (kg/m\^2) at each assessment., Baseline and Week 16 | Secondary: Weight (kg), Weight in kilograms will be measured at each assessment and change will be determined at study endpoint., Baseline and Week 16|Health Risk Markers, 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, Baseline to Week 16|Waist Circumference (Inches), Waist circumference will be measured in inches at each assessment., Baseline and Week 16
|
| Sponsor/Collaborators: |
Sponsor: Yale University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
5
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-06-01
|
| Completion Date: |
2018-07-31
|
| Results First Posted: |
2019-08-07
|
| Last Update Posted: |
2019-08-07
|
| Locations: |
Connecticut Mental Health Center, New Haven, Connecticut, 06519, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03132571
|
