Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
Status
Completed
Conditions
Schizophrenia
Schizoaffective Disorder
Obesity
Treatments
Drug: Naltrexone 25mg
Other: Placebo
Details and patient eligibility
About
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.
Enrollment
24 patients
Sex
Female
Ages
18 to 70 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
24 participants in 2 patient groups, including a placebo group
Naltrexone 25mg
Active Comparator group
Treatment:
Drug: Naltrexone 25mg
Placebo
Placebo Comparator group
Treatment:
Other: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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