N/A
Completed N=24
Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia
Source: ClinicalTrials.gov NCT00793780 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Change in Body Weight From Baseline — -3.40; 1.37 kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight From Baseline |
-3.40; 1.37 | — |
| SECONDARY Fasting Serum Glucose Lab Values |
113.40; 93.82; 129.22; 94.11 | — |
| SECONDARY PANSS- Positive and Negative Symptom Scale |
57.50; 52.63 | — |
| SECONDARY Insulin Levels |
26.42; 13.84; 35.51; 12.36 | — |
| SECONDARY LDL Cholesterol |
86.80; 123.18; 104.11; 111.22 | — |
| SECONDARY Change in Questionnaire on Craving for Sweet or Rich Foods Score |
-3.10; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00793780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.