Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Antipsychotic Agents; Aripiprazole; Olanzapine

Criteria

Inclusion Criteria:

• Meets DSM-IV criteria for AN (DSM-IV criteria for amenorrhea will not be strictly applied, as these patients have been shown to be clinically indistinguishable from those with full criteria AN)

• Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2 (BMI of 19 is equivalent to approximately 85% of ideal body weight [IBW] according to Metropolitan Life standards, and BMI of 14 is equivalent to approximately 65% IBW)

• Unwilling to pursue inpatient treatment if BMI is less than 18 kg/m2

• Free of psychotropic (e.g., antidepressant, antianxiety, mood stabilizer, antipsychotic) medication for 2 weeks before study entry (free for 4 weeks before study entry if taking fluoxetine or antipsychotic medications)

• Prior treatment of AN

Exclusion Criteria:

• Any medical or psychiatric problem requiring urgent clinical attention (e.g., metabolic disturbance, acute suicidality) and/or significant comorbid illnesses that are not likely to benefit from proposed treatments

• Significant orthostatic high blood pressure (systolic change greater than 30 mmHg upon changing from supine to standing position)

• Allergy to olanzapine or aripiprazole

• Commencing psychotherapy in the community within 3 months of study entry

• Diabetes mellitus, with fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose less than 140 mg/dL

• Known history of current or past jaundice

• Known history of narrow angle glaucoma

• Active substance abuse or dependence

• Schizophrenia, schizophreniform disorder, or bipolar illness

• Movement disorder or presence of tics

• History of tardive dyskinesia

• History of seizures

• Pregnant