Status:
COMPLETED
Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Eating Disorders
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.
Detailed Description
Anorexia nervosa (AN) is a disease of disordered eating that is characterized by self-starvation, often leading to extreme weight loss and difficulty maintaining a normal weight. Symptoms and behavior...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00685334
Start Date
November 1 2003
End Date
September 1 2006
Last Update
October 29 2013
Active Locations (2)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032
2
Toronto General Hospital
Toronto, Ontario, Canada, M5G2C4