Clinical trial NCT00793780: Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
Official title: Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Schizophrenia
Schizoaffective Disorder
Keywords: obesity
schizophrenia
schizoaffective disorder
weight loss
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Ethel F. Donaghue Women's Health Investigator Program at Yale
First posted: 2008-11-19
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change in Body Weight From Baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Fasting Serum Glucose Lab Values
timeFrame: baseline and 8 weeks
measure: PANSS- Positive and Negative Symptom Scale
timeFrame: 8 weeks
measure: Insulin Levels
timeFrame: baseline and week 8
measure: LDL Cholesterol
timeFrame: baseline and week 8
measure: Change in Questionnaire on Craving for Sweet or Rich Foods Score
timeFrame: baseline and week 8
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Cenk Tek, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.