Overview

This trial is active, not recruiting.

Condition anorexia nervosa
Treatments risperidone or placebo, risperidone
Phase phase 4
Sponsor University of Colorado, Denver
Collaborator Janssen Pharmaceuticals
Start date August 2004
End date December 2009
Trial size 41 participants
Trial identifier NCT00140426, 03-673, M01-RR00069

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
risperidone or placebo Risperdal
risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.
(Active Comparator)
Study is double blind, placebo controlled. This is the subject group on active medication
risperidone risperdal
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.

Primary Outcomes

Measure
Change in body image distortion and body satisfaction
time frame: monthly
Change in Eating Disorder Inventory-2 Score
time frame: monthly
Number of days from start of study to reach ease of eating level 3 (Normal eating behavior)
time frame: weekly

Secondary Outcomes

Measure
Time to reach 90% ideal body weight (IBW) and maintain for 1 month, stratified by %IBW at start of study
time frame: weekly
Change in ratings of anxiety symptoms on the MASC
time frame: monthly
Change in leptin levels
time frame: monthly
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

Eligibility Criteria

Female participants from 12 years up to 21 years old.

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

Additional Information

Official title A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Principal investigator Jennifer O Hagman, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.