Official Title: “A Double-Blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Risperidone or placebo
  • risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
• Experimental: 2
  • Study is double blind, placebo controlled. This is the subject group on active medication

Primary Measures

• Change in body image distortion and body satisfaction
  • Time Frame: during study enrollment
    Safety Issue?: No
• Change in Eating Disorder Inventory-2 Score
  • Time Frame: during study enrollment
    Safety Issue?: No
• Number of days from start of study to reach ease of eating level 3 (Normal eating behavior)
  • Time Frame: during study enrollment
    Safety Issue?: No

Secondary Measures

• Time to reach 90% IBW and maintain for 1 month, stratified by %IBW at start of study
  • Time Frame: during study enrollment
    Safety Issue?: No
• Change in ratings of anxiety symptoms on the MASC
  • Time Frame: during study enrollment
    Safety Issue?: No
• Change in leptin levels
  • Time Frame: during study enrollment
    Safety Issue?: Yes
• 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.
  • Time Frame: during study enrollment
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 21 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The Children's Hospital, Denver

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Jennifer O Hagman, MD 720-777-2539 hagman.jennifer@tchden.org

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00140426

Study ID Number: RIS-EMR-4009, GCRC #728

ClinicalTrials.gov Identifier: NCT00140426

Health Authority: United States: Institutional Review Board