MedTrace Logo

Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in Schizophrenia

NCT03132571 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-08-07

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine the efficacy of combining open-label extended release bupropion (flexible dosing up to 450mg target) and naltrexone (37.5mg) versus Bupropion and placebo along with a daily 500 calorie reduction diet recommendation for weight and health risk reduction in 40 overweight/obese individuals with schizophrenia.

Conditions

Interventions

DRUG

Naltrexone

37.mg oral capsule taken once daily for over the course of the study (16 weeks)

DRUG

Bupropion

Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.

OTHER

Placebo

Oral placebo taken once daily for the course of the study (16 week)

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Cenk Tek, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2018-07-31
Completion
2018-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03132571 on ClinicalTrials.gov