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

NCT03132571 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 1606017928
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia; Diabetes Mellitus, Type 2; Obesity

Keywords

Schizophrenia; Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• BMI

  BMI will be calculated using weekly height and weight measurements (kg/m\^2) at each assessment.

  Baseline and Week 16

Secondary Outcomes (3)

• Weight (kg)

  Baseline and Week 16

• Health Risk Markers

  Baseline to Week 16

• Waist Circumference (Inches)

  Baseline and Week 16

Study Arms (2)

Naltrexone with Bupropion

EXPERIMENTAL

Oral Naltrexone taken once a day and Oral Bupropion taken once a day for 16 weeks.

Drug: Naltrexone; Drug: Bupropion

Placebo with Bupropion

PLACEBO COMPARATOR

Oral placebo capsule and Oral Bupropion taken once a day for 16 weeks.

Drug: Bupropion; Other: Placebo

Interventions

Naltrexone DRUG

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

Also known as: Revia

Naltrexone with Bupropion

Bupropion DRUG

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

Also known as: Wellbutrin, Zyban

Naltrexone with Bupropion; Placebo with Bupropion

Placebo OTHER

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

Placebo with Bupropion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75
• Meet DSM-IV criteria for schizophrenia or schizoaffective disorder based on SCID interview (If bipolar-schizoaffective: need to be adequately stabilized on a mood stabilizer and show no mania history for the past one year, as confirmed by study psychiatrist and patient's clinician)
• Body Mass Index (BMI) of 28 and over
• On a stable dose of antipsychotic medication; i.e. at least one month with no dose change, and three months from an antipsychotic switch
• Deemed to be symptomatically stable by the clinical staff in the last two months
• Over 7% total body weight increase on antipsychotics for subjects within first year of illness

You may not qualify if:

• Meet criteria for current opiate abuse or dependence (confirmed by positive urine drug screen for opiates or, if suspected by study doctor via patient history and or suspicion of occult opiate use.) Note: All subjects will be screened for drugs, not only those suspected of opiate use.
• A history of seizures in the past five years (confirmed through chart review and discussion with patient's clinician)
• Meet DSM criteria for Bipolar Disorder
• History of mania in the past one year (confirmed through chart review and discussion with patient's clinician)
• Uncontrolled hypertension
• Insulin dependent diabetes mellitus
• Current history of dementia, mental retardation
• Not capable of giving informed consent for participation in the study
• Women who are pregnant or breast-feeding
• Physical conditions affecting body weight (e.g. Cushing's disease, polycystic ovary syndrome)
• Severe liver dysfunction, (serum aminotransferases greater than three times normal), acute infectious hepatitis, liver failure.
• History of glaucoma.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Schizophrenia; Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus

Interventions

Naltrexone; Bupropion

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Dr. Cenk Tek
• Organization: Yale School of Medicine, Department of Psychiatry

cenk.tek@yale.edu

(203) 974-7500

Study Officials

• Cenk Tek, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Naltrexone versus Placebo assignment will remain double-blinded for the duration of the study; Bupropion dosing will be open-label and not masked to either participant or investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 28, 2017
• Study Start: June 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 7, 2019
• Results First Posted: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)