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Sponsors and Collaborators: |
North Shore Long Island Jewish Health System Eli Lilly and Company |
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Information provided by: | North Shore Long Island Jewish Health System |
ClinicalTrials.gov Identifier: | NCT00592930 |
This study compared 10 weeks of treatment with olanzapine versus placebo in adolescent females with anorexia nervosa-restricting type who were undergoing acute treatment on an inpatient unit or a day hospital program that specializes in the treatment of eating disorders.
Condition | Intervention | Phase |
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Anorexia Nervosa |
Drug: olanzapine Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of the Efficacy of Olanzapine in the Treatment of Anorexias Nervosa |
Estimated Enrollment: | 20 |
Study Start Date: | June 2000 |
Estimated Study Completion Date: | December 2004 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
olanzapine
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Drug: olanzapine
flexibly dosed oral olanzapine 2.5 to 15 mg/day
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2: Placebo Comparator
matching placebo
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Drug: placebo |
Ages Eligible for Study: | 12 Years to 23 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Schneider Children's Hospital | |
New Hyde Park, New York, United States, 11040 |
Principal Investigator: | Vivian Kafantaris, M.D. | Schneider Children's Hospital |
Responsible Party: | North Shore- Long Island Jewish Health System ( Vivian Kafantaris, M. D. ) |
Study ID Numbers: | 99-04-072, Lilly F1D-US-X166 |
Study First Received: | January 2, 2008 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00592930 |
Health Authority: | United States: Institutional Review Board |
anorexia nervosa, treatment, adolescents, olanzapine |
Signs and Symptoms Signs and Symptoms, Digestive Mental Disorders Olanzapine |
Anorexia Anorexia Nervosa Serotonin Eating Disorders |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |