Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa Risperidone Atypical Neuroleptics Dopamine Leptin Body Image Adolescents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo. arm 2: Study is double blind, placebo controlled. This is the subject group on active medication

Interventions: intervention 1: Risperidone intervention 2: Placebo
Intervention descriptions: intervention 1: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks. intervention 2: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.

Protocol document: