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

Condition(s) targeted: Anorexia Nervosa

Intervention: Risperidone or placebo (Drug); Risperidone (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Jennifer O Hagman, MD, Principal Investigator, Affiliation: University of Colorado, Health Sciences Center and The Children's Hospital, Denver

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change in body image distortion and body satisfaction

Change in Eating Disorder Inventory-2 Score

Number of days from start of study to reach ease of eating level 3 (Normal eating behavior)

Secondary outcome:

Time to reach 90% ideal body weight (IBW) and maintain for 1 month, stratified by %IBW at start of study

Change in ratings of anxiety symptoms on the MASC

Change in leptin levels

Safety and tolerability of risperidone as measured by liver enzymes, prolactin levels, triglycerides, glucose, cholesterol, ECG, resting energy expenditure (REE) and side effect rating scales - Simpson and AIMS.

Detailed description: 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.

Minimum age: 12 Years. Maximum age: 21 Years. Gender(s): Female.

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

The Children's Hospital, Denver, Colorado 80218, United States

Starting date: August 2004
Last updated: March 5, 2013