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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):
Cenk Tek, Yale University
ClinicalTrials.gov Identifier:
NCT00793780
First received: November 18, 2008
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • The primary outcome measure is change in body weight from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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

No publications provided

Responsible Party: Cenk Tek, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00793780     History of Changes
Other Study ID Numbers: 0808004106
Study First Received: November 18, 2008
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Psychotic Disorders
Schizophrenia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
 Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013