Status:
COMPLETED
A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Janssen Pharmaceuticals
National Center for Research Resources (NCRR)
Conditions:
Anorexia Nervosa
Eligibility:
FEMALE
12-21 years
Phase:
PHASE4
Brief 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 i...
Detailed Description
The lack of effective medications for the symptoms of anorexia nervosa (AN), combined with early promising findings in case reports (Risperidone and Olanzapine) and one open study of olanzapine have l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00140426
Start Date
August 1 2004
End Date
December 1 2009
Last Update
February 2 2016
Active Locations (1)
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1
The Children's Hospital
Denver, Colorado, United States, 80218