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Denver, Colorado 80218


Purpose:

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 summary:

The lack of effective medications for the symptoms of anorexia nervosa (AN), combined wit early promising findings in case reports (Risperidone and Olanzapine) and one open study of olanzapine have led to increased use of these medications for individuals with AN. This double-blind placebo controlled study of risperidone will attempt to determine if risperidone is effective in decreasing core symptoms of anorexia nervosa and decreasing the length of time required to reach and maintain at or about 90% Ideal body weight. The safety of risperidone in this population will also be examined through monitoring of Extrapyramidal Symptoms, Tardive Dyskinesia, Electrocardiograms's, Resting Energy Expenditure, liver enzymes and other blood chemistry. Other possible variables which may mediate the recovery process or be impacted by risperidone,such as leptin and anxiety symptoms are also being measured.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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


NCT ID:

NCT00140426


Primary Contact:

Principal Investigator
Jennifer O Hagman, MD
University of Colorado, Health Sciences Center and The Children's Hospital, Denver


Backup Contact:

N/A


Location Contact:

Denver, Colorado 80218
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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