Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

Yale University24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obesity Schizophrenia Schizoaffective Disorder

Interventions

Naltrexone 25mgDRUG

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

PlaceboOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Connecticut Mental Health Center

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Change in Body Weight From Baseline

Weight was measured with shoes off to the nearest 0.1 kg.

Time frame: 8 weeks

Secondary Outcomes

Fasting Serum Glucose Lab Values

Time frame: 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.

Time frame: 8 weeks

Insulin Levels

Determined with a double-antibody radioimmunoassay

Time frame: baseline and week 8

LDL Cholesterol

Determined by standard enzymatic procedures

Time frame: 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.

Time frame: baseline and week 8

Data from ClinicalTrials.gov

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