Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

Obesity Clinical Trial

Official title:

Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793780
• Other study ID #: 0808004106
• Status: Completed
• Phase: N/A
• First received: November 18, 2008
• Last updated: August 12, 2016
• Start date: December 2008
• Est. completion date: November 2010

Study information

• Verified date: August 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

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

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Ethel F. Donaghue Women's Health Investigator Program at Yale

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight From Baseline	Weight was measured with shoes off to the nearest 0.1 kg.	8 weeks
Secondary	Fasting Serum Glucose Lab Values		baseline and 8 weeks
Secondary	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
Secondary	Insulin Levels	Determined with a double-antibody radioimmunoassay	baseline and week 8
Secondary	LDL Cholesterol	Determined by standard enzymatic procedures	baseline and week 8
Secondary	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