Phase 2 N=23 Randomized Quadruple-blind Treatment

Effectiveness of Olanzapine Versus Placebo in Treating Outpatients With Anorexia Nervosa

Eating Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00692185 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2009

Primary outcome: Primary: Weight Gain — 6.2; 1.5 lbs

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Olanzapine (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Weight Gain	6.2; 1.5	—
SECONDARY Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale	19.4; 18.9	—

Summary

This study will evaluate the effectiveness of the antipsychotic medication olanzapine in treating outpatients with anorexia nervosa.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00692185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.