Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

NCT ID: NCT00793780

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-11-30

Brief Summary

The purpose of this clinical trial is to find out how effective low dose oral naltrexone is on reducing body weight when compared to placebo in women with schizophrenia and schizoaffective disorder.

Conditions

Obesity; Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Naltrexone 25mg

Group Type: ACTIVE_COMPARATOR

Naltrexone 25mg

Intervention Type: DRUG

Naltrexone 25mg caplets taken orally once a day for 8 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo caplet (inactive substance) taken orally once a day for 8 weeks

Interventions

Naltrexone 25mg

Naltrexone 25mg caplets taken orally once a day for 8 weeks

Intervention Type: DRUG

Placebo

Placebo caplet (inactive substance) taken orally once a day for 8 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women between the ages of 18 to 70
• Meet DSM-IV (Diagnostic and Statistical Manual version IV) criteria for schizophrenia or schizoaffective disorder based on SCID (Structured Clinical Interview for the DSM-IV) interview
• Overweight, as defined with a BMI of equal to or greater than 27 kg/m² and continuing weight gain in the past year above 2% of previous years total body weight
• Be on a stable dose of antipsychotic medication; i.e. at least one month with no dosage change, and two months from an antipsychotic switch; 5) Deemed to be symptomatically stable by the clinical staff in the last two months

Exclusion Criteria

• Meet criteria for current alcohol or other substance dependence, opioid use for any reason or positive urine drug screen for opiates
• A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings
• Not capable of giving informed consent for participation in this study
• Ongoing pregnancy
• Known sensitivity to naltrexone
• A medical disorder that is known to cause obesity
• Use of sibutramine, topiramate, amphetamines or over the counter weight remedies
• Impaired liver functions (greater than 3 times the upper limit of normal)
• Diagnosed with polycystic ovary syndrome
• Currently being treated with insulin
• Current use of Depo-Provera or any natural/synthetic hormone treatment known to cause significant weight gain

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ethel F. Donaghue Women's Health Investigator Program at Yale

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cenk Tek, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Connecticut Mental Health Center

New Haven, Connecticut, United States

Countries

United States

References

Tek C, Ratliff J, Reutenauer E, Ganguli R, O'Malley SS. A randomized, double-blind, placebo-controlled pilot study of naltrexone to counteract antipsychotic-associated weight gain: proof of concept. J Clin Psychopharmacol. 2014 Oct;34(5):608-12. doi: 10.1097/JCP.0000000000000192.

Reference Type: RESULT

PMID: 25102328 (View on PubMed)

Other Identifiers

0808004106

Identifier Type: -

Identifier Source: org_study_id