A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Completed · Phase 4 · Has a placebo group
Conditions studied: Anorexia Nervosa
In brief
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.
Key facts
- Study ID
- NCT00140426
- Run by
- University of Colorado, Denver
- People needed
- 41
- Starts
- 2004-08-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2016-02-02
Who can join
Age: 12 and older, up to 21. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Primary Diagnosis of Anorexia Nervosa
- Female, age 12-21
- Active in a level of care for AN at The Children's Hospital, Denver
- As long as there is a primary dx of AN, co-morbid diagnoses may be included.
- If taking an antidepressant, must be on a stable dose for 3 weeks prior to entering the study, and dose of antidepressant may not be changed during Phase 1 of the study.
- If choosing to discontinue antidepressant medication, must be off the medication for 3 weeks prior to beginning the study.
- If sexually active, must use birth control during the study and have a monthly pregnancy test.
You may not qualify if…
- 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
- Taking a psychotropic medication other than antidepressant and discontinuing the medication is not recommended.
- Active hepatic or renal disease
- Wards of the state
- Males
Where it is running
- The Children's Hospital — Denver, Colorado, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.