Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia - Full Text View

Sponsors and Collaborators:	Yale University Ethel F. Donaghue Women's Health Investigator Program at Yale
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00793780

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

MedlinePlus related topics: Obesity Schizophrenia

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

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 ]

Estimated Enrollment:	30
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Naltrexone 25mg: Active Comparator	Drug: Naltrexone 25mg Naltrexone 25mg caplets taken orally once a day for 8 weeks
Placebo: Placebo Comparator	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

Contacts

Contact: Pamela DeGeorge, M.S.

203-974-7317

pamela.degeorge@yale.edu

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

Responsible Party:	Yale University School of Medicine ( Cenk Tek, M.D. Principal Investigator )
Study ID Numbers:	0808004106
Study First Received:	November 18, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00793780
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

obesity
schizophrenia
schizoaffective disorder
weight loss

Study placed in the following topic categories:

Schizophrenia
Body Weight
Signs and Symptoms
Obesity
Mental Disorders
Naltrexone

Weight Loss
Nutrition Disorders
Overweight
Overnutrition
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009