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% IBW sooner than controls.

Condition	Intervention	Phase
Anorexia Nervosa	Drug: Risperidone	Phase IV

Further Study Details: 

Primary Outcomes: 1. Change in body image distortion and body satisfaction; 2. Change in Eating Disorder Inventory-2 Score; 3. Number of days from start of study to reach ease of eating level 3 (Normal eating behavior)
Secondary Outcomes: 1. Time to reach 90% IBW and maintain for 1 month, stratified by %IBW at start of study; 2. Change in ratings of anxiety symptoms on the MASC; 3. Change in leptin levels; 4. Safety and tolerability of risperidone as measured by liver enzymes, prolactin levels, triglycerides, glucose, cholesterol, ECG, REE and side effect rating scales - Simpson and AIMS.
Expected Total Enrollment:  50

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% IBW. The safety of risperidone in this population will also be examined through monitoring of EPS, TD, ECG''''s, REE, 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.

Ages Eligible for Study:  12 Years   -   21 Years,  Genders Eligible for Study:  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

Please refer to this study by ClinicalTrials.gov identifier  NCT00140426

Jennifer O Hagman, MD      303-837-2539    hagman.jennifer@tchden.org
Eric Sigel, MD      303-837-2636    sigel.eric@tchden.org

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

Study chairs or principal investigators

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

Study ID Numbers:  RIS-EMR-4009, GCRC #728; M01-RR00069
Last Updated:  August 31, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00140426
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06