Status:
COMPLETED
Effectiveness of Olanzapine Versus Placebo in Treating 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:
PHASE2
Brief Summary
This study will evaluate the effectiveness of the antipsychotic medication olanzapine in treating outpatients with anorexia nervosa.
Detailed Description
Anorexia nervosa (AN) is a disease of disordered eating and is characterized by self-starvation, extreme weight loss, and difficulty maintaining a normal weight. Symptoms and behaviors of AN may inclu...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria (not including amenorrhea) for AN
- Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2
- Patient (or family if the patient is a minor) refuses hospitalization
- Free of psychotropic medication (4 weeks medication free for fluoxetine and antipsychotic medication; 2 weeks medication free for all others) OR on a stable dose of an SSRI or SNRI (venlafaxine) for 4 weeks before study entry
- Prior treatment of AN
Exclusion
- Any medical or psychiatric problem requiring urgent attention and/or any significant comorbid illness not likely to benefit from proposed treatments
- Allergy to olanzapine
- Significant orthostatic high blood pressure
- Recent commencement of psychotherapy in the community
- Diabetes mellitus, with a fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose greater 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 :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00692185
Start Date
October 1 2005
End Date
September 1 2010
Last Update
May 10 2019
Active Locations (1)
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1
Eating Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032