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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

November 18, 2008
August 12, 2016
December 2008
November 2010   (final data collection date for primary outcome measure)
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.
The primary outcome measure is change in body weight from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00793780 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
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
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: 10.1097/JCP.0000000000000192.

*   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 (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
Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00793780
0808004106
No
Not Provided
Not Provided
Yale University
Yale University
Ethel F. Donaghue Women's Health Investigator Program at Yale
Principal Investigator: Cenk Tek, M.D. Yale University
Yale University
August 2016

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