Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

Conditions
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Obesity, Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Naltrexone 25mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naltrexone 25mg<br> | Drug: Naltrexone 25mg<br>* Naltrexone 25mg caplets taken orally once a day for 8 weeks<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo caplet (inactive substance) taken orally once a day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight From Baseline | Weight was measured with shoes off to the nearest 0.1 kg. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Serum Glucose Lab Values |  | baseline and 8 weeks | 
| PANSS- Positive and Negative Symptom Scale | 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. | 8 weeks | 
| Insulin Levels | Determined with a double-antibody radioimmunoassay | baseline and week 8 | 
| LDL Cholesterol | Determined by standard enzymatic procedures | baseline and week 8 | 
| Change in Questionnaire on Craving for Sweet or Rich Foods Score | 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. | baseline and week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, schizophrenia, schizoaffective disorder, weight loss