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Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Ethel F. Donaghue Women's Health Investigator Program at Yale
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00793780
First received: November 18, 2008
Last updated: August 12, 2016
Last verified: August 2016
  Purpose
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 Intervention
Obesity
Schizophrenia
Schizoaffective Disorder
Drug: Naltrexone 25mg
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in Body Weight From Baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Weight was measured with shoes off to the nearest 0.1 kg.


Secondary Outcome Measures:
  • Fasting Serum Glucose Lab Values [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • PANSS- Positive and Negative Symptom Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Insulin Levels [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
    Determined with a double-antibody radioimmunoassay

  • LDL Cholesterol [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
    Determined by standard enzymatic procedures

  • Change in Questionnaire on Craving for Sweet or Rich Foods Score [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: December 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793780

Locations
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
Principal Investigator: Cenk Tek, M.D. Yale University
  More Information

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00793780     History of Changes
Other Study ID Numbers: 0808004106 
Study First Received: November 18, 2008
Results First Received: June 28, 2016
Last Updated: August 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
obesity
schizophrenia
schizoaffective disorder
weight loss

Additional relevant MeSH terms:
Obesity
Schizophrenia
Psychotic Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on December 09, 2016