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):
Cenk Tek, Yale University
ClinicalTrials.gov Identifier:
NCT00793780
First received: November 18, 2008
Last updated: March 28, 2014
Last verified: March 2014

November 18, 2008
March 28, 2014
December 2008
November 2010   (final data collection date for primary outcome measure)
The primary outcome measure is change in body weight from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00793780 on ClinicalTrials.gov Archive Site
  • Change in lab values from baseline (fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in questionnaires and assessments (Q-LES-Q, PANSS, Food Craving Scale, Food Frequency Scale, Food Preference Scale) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Schizophrenia
  • Schizoaffective Disorder
  • 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
  • Active Comparator: Naltrexone 25mg
    Intervention: Drug: Naltrexone 25mg
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women between the ages of 18 to 70
  • Meet DSM-IV criteria for schizophrenia or schizoaffective disorder based on SCID 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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00793780
0808004106
No
Cenk Tek, Yale University
Yale University
Ethel F. Donaghue Women's Health Investigator Program at Yale
Principal Investigator: Cenk Tek, M.D. Yale University
Yale University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP