A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Janssen Pharmaceuticals; National Center for Research Resources (NCRR)
• Treatments: Risperidone

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