We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Olanzapine in the Treatment of Anorexia Nervosa

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00592930
First Posted: January 14, 2008
Last Update Posted: January 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by:
Northwell Health
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • weight gain [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • measures of psychiatric symptoms [ Time Frame: 10 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females, ages 12-23

Exclusion Criteria:

  • Binge-purge type
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592930


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

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
First Submitted: January 2, 2008
First Posted: January 14, 2008
Last Update Posted: January 14, 2008
Last Verified: January 2008

Keywords provided by Northwell Health:
anorexia nervosa, treatment, adolescents, olanzapine

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