A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 12 - 21 |
| Updated: | 4/21/2016 |
| Start Date: | August 2004 |
| End Date: | December 2009 |
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.
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.
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 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.
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.
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
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