A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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 satisfactionChange 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 studyChange 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.
Eligibility
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
Locations and Contacts
The Children's Hospital, Denver, Colorado 80218, United States
Additional Information
Starting date: August 2004
Last updated: March 5, 2013
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