Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa
Completed · Phase 4
Conditions studied: Eating Disorders
In brief
This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.
Key facts
- Study ID
- NCT00685334
- Run by
- New York State Psychiatric Institute
- People needed
- 22
- Starts
- 2003-11-01
- Expected to finish
- 2006-09-01
- Last updated by the study team
- 2013-10-29
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- New York State Psychiatric Institute — New York, New York, United States
- Toronto General Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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