ISRCTN23032339CompletedNot Applicable
A randomised, double-blind, placebo-controlled trial to evaluate the efficacy and tolerability of olanzapine as adjunctive treatment for anorexia nervosa in touth: a pilot study
Children's Hospital of Eastern Ontario (Canada)0 sites50 target enrollmentStarted: November 4, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Must give written informed consent or assent
- •2. Must be female
- •3. Must be between age 12 and 17 (younger than 18) at beginning of trial
- •4. Based on the Diagnostic and Statistical Manual of Mental Disorders (4th Edition ? Revised, American Psychiatric Association [APA], 2000) must have fulfilled the criteria for diagnosis of Anorexia Nervosa or Eating Disorder Not Otherwise Specified with a Body Mass Index =17
Exclusion Criteria
- •1. Subject has known sensitivity to any of the products to be administered
- •2. Treatment with any other anti-psychotic medication, mood stabiliser, stimulant
- •3. Treatment with medication known to interact with olanzapine e.g. fluvoxamine, ciprofloxacin
- •4. Medical illness such as: diabetes, impaired glucose tolerance, hyperlipidemia, hepatic dysfunction, substance abuse, narrrow angle glaucoma, paralytic ileus, or pancreatitis
- •5. Subject?s inability to comply with trial requirements including lack of comprehension of English
- •6. Other unspecified reasons that, in the opinion of the Investigator, make subject unsuitable for enrollment
- •7. Subject is pregnant or is breast-feeding
- •8. Laboratory exclusion criteria:
- •a. Total white cell count <2.5
- •b. Neutrophil count <1.0
- •c. Liver function tests (aspartate transaminase (AST)/alanine transaminase (ALT) >2 X normal)
- •d. Positive pregnancy test
- •e. Electrocardiogram (EKG) ? QTc >440 msec or arrythmia other than sinus bradycardia; conduction abnormalities prolonged QTc or other
Investigators
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