A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Anorexia Nervosa

Treatments: Drug: Placebo; Drug: Risperidone

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00140426

5M01RR000069-45 (U.S. NIH Grant/Contract)

03-0673

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 41 patients

Sex: Female

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.

Treatment:

Drug: Placebo

risperidone

Active Comparator group

Description:

Study is double blind, placebo controlled. This is the subject group on active medication

Treatment:

Drug: Risperidone