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% Ideal body weight sooner than controls.
Drug: Risperidone or placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa|
- Change in body image distortion and body satisfaction [ Time Frame: monthly ] [ Designated as safety issue: No ]
- Change in Eating Disorder Inventory-2 Score [ Time Frame: monthly ] [ Designated as safety issue: No ]
- Number of days from start of study to reach ease of eating level 3 (Normal eating behavior) [ Time Frame: weekly ] [ Designated as safety issue: No ]
- Time to reach 90% ideal body weight (IBW) and maintain for 1 month, stratified by %IBW at start of study [ Time Frame: weekly ] [ Designated as safety issue: No ]
- Change in ratings of anxiety symptoms on the MASC [ Time Frame: monthly ] [ Designated as safety issue: No ]
- Change in leptin levels [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
- 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. [ Time Frame: baseline, week 8 and study end visit ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||July 2013|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Placebo Comparator: risperidone or placebo
double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Drug: Risperidone or placebo
risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.
Other Name: Risperdal
Active Comparator: risperidone
Study is double blind, placebo controlled. This is the subject group on active medication
Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW.
Other Name: risperdal
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.
|United States, Colorado|
|The Children's Hospital|
|Denver, Colorado, United States, 80218|
|Principal Investigator:||Jennifer O Hagman, MD||University of Colorado, Health Sciences Center and The Children's Hospital, Denver|