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Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00793780
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : October 6, 2016
Last Update Posted : October 6, 2016
Sponsor:
Collaborator:
Ethel F. Donaghue Women's Health Investigator Program at Yale
Information provided by (Responsible Party):
Yale University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Schizophrenia Schizoaffective Disorder Drug: Naltrexone 25mg Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
Study Start Date : December 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Naltrexone 25mg Drug: Naltrexone 25mg
Naltrexone 25mg caplets taken orally once a day for 8 weeks
Placebo Comparator: Placebo Other: Placebo
Placebo caplet (inactive substance) taken orally once a day for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in Body Weight From Baseline [ Time Frame: 8 weeks ]
    Weight was measured with shoes off to the nearest 0.1 kg.


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793780


Locations
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United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Ethel F. Donaghue Women's Health Investigator Program at Yale
Investigators
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Principal Investigator: Cenk Tek, M.D. Yale University
More Information
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Publications of Results:

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00793780    
Other Study ID Numbers: 0808004106
First Posted: November 19, 2008    Key Record Dates
Results First Posted: October 6, 2016
Last Update Posted: October 6, 2016
Last Verified: August 2016
Keywords provided by Yale University:
obesity
schizophrenia
schizoaffective disorder
weight loss
Additional relevant MeSH terms:
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Obesity
Schizophrenia
Psychotic Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Schizophrenia Spectrum and Other Psychotic Disorders
 Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents