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Olanzapine in the Treatment of Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00592930
First received: January 2, 2008
Last updated: January 11, 2008
Last verified: January 2008
History of Changes
  Purpose

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
Anorexia Nervosa
 Drug: olanzapine
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of the Efficacy of Olanzapine in the Treatment of Anorexias Nervosa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • weight gain [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • measures of psychiatric symptoms [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

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
Experimental: 1
olanzapine
 Drug: olanzapine
flexibly dosed oral olanzapine 2.5 to 15 mg/day
Placebo Comparator: 2
matching placebo
 Drug: placebo

  Eligibility

Ages Eligible for Study:   12 Years to 23 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females, ages 12-23

Exclusion Criteria:

  • Binge-purge type
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592930

Locations
United States, New York
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Eli Lilly and Company
Investigators
Principal Investigator: Vivian Kafantaris, M.D. Schneider Children's Hospital
  More Information

No publications provided by North Shore Long Island Jewish Health System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vivian Kafantaris, M. D., North Shore- Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00592930     History of Changes
Other Study ID Numbers: 99-04-072, Lilly F1D-US-X166
Study First Received: January 2, 2008
Last Updated: January 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
anorexia nervosa, treatment, adolescents, olanzapine

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2013