Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

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 Overview

• Status: Completed
• Conditions: Obesity; Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: Naltrexone 25mg; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Connecticut Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Ethel F. Donaghue Women's Health Investigator Program at Yale

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: November 18, 2008
• First Submitted That Met QC Criteria: November 18, 2008
• First Posted (Estimate): November 19, 2008

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: August 12, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: obesity; schizophrenia; schizoaffective disorder; weight loss
• Additional Relevant MeSH Terms: Mental Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Schizophrenia Spectrum and Other Psychotic Disorders; Obesity; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: 0808004106