Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

Not Applicable

Completed

• Conditions: Schizoaffective Disorder; Obesity; Schizophrenia
• Interventions: Drug: Naltrexone 25mg; Other: Placebo

• Registration Number: NCT00793780
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-11-18
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Study Start: 2008-12
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Disposition First Submitted: 2012-01-25
• Disposition First Submitted QC: 2012-01-25
• Disposition First Posted: 2012-01-30
• Results First Submitted: 2016-06-28
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-12
• Last Update Submitted: 2016-08-12
• Results First Posted: 2016-10-06
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naltrexone 25mg	Naltrexone 25mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Body Weight From Baseline	8 weeks	Weight was measured with shoes off to the nearest 0.1 kg.

Secondary Outcome Measures

Name	Time	Method
Change in Questionnaire on Craving for Sweet or Rich Foods Score	baseline and week 8	The Questionnaire on Craving for Sweet or Rich Foods (QCSRF) is a 2-factor, 9-item scale assessing the presence of cravings for rich and sweet foods and has been found to have good psychometric properties. The total score is the total of 2 sub scales. Total range is from 9 to 63, with a higher score indicative of a higher craving and reinforcement from sweet and/or rich foods.
Insulin Levels	baseline and week 8	Determined with a double-antibody radioimmunoassay
LDL Cholesterol	baseline and week 8	Determined by standard enzymatic procedures
Fasting Serum Glucose Lab Values	baseline and 8 weeks
PANSS- Positive and Negative Symptom Scale	8 weeks	The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Total score ranges from a minimum of 30 to a maximum of 210. A higher score indicates more severe symptoms.

Trial Locations

Locations (1)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States