At a glance
ClinicalIndex Comparison Record- ✓Primary diagnosis of anorexia nervosa
- ✓Female, age 12–21 years
- ✓Currently enrolled in a level of care for anorexia nervosa at The Children's Hospital, Denver
- ✓If on antidepressant, must be on stable dose for ≥3 weeks prior to enrollment and dose cannot change during Phase 1; alternatively, must be off antidepressant for ≥3 weeks before starting
- ✕Previous enrollment in this study on a prior admission
- ✕Previous allergic reaction to risperidone or other atypical neuroleptic
- ✕Positive pregnancy test
- ✕Neurologic disorder other than benign essential tremor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
In Brief
A Phase 4 clinical trial evaluating Risperidone and Placebo for Anorexia Nervosa. Completed, enrolled 41 participants across 1 site.
Detailed Summary
The aim of this pilot study is to determine the safety and efficacy of risperidone for the treatment of anorexia nervosa. Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image distortion and Eating Disorder Inventory -2 scores than subjects on placebo. Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body weight sooner than controls.
Study Details
Timeline
Interventions
risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.
Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.