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Completed

NCT Number: NCT00793780

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone 25mg

Drug

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

Placebo

Other

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

Primary outcomes

  1. Change in Body Weight From Baseline

    Time frame: 8 weeks

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

Secondary outcomes

  1. Fasting Serum Glucose Lab Values

    Time frame: baseline and 8 weeks

  2. PANSS- Positive and Negative Symptom Scale

    Time frame: 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.

  3. Insulin Levels

    Time frame: baseline and week 8

    Determined with a double-antibody radioimmunoassay

  4. LDL Cholesterol

    Time frame: baseline and week 8

    Determined by standard enzymatic procedures

  5. Change in Questionnaire on Craving for Sweet or Rich Foods Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Ethel F. Donaghue Women's Health Investigator Program at Yale

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 19, 2008
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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