Olanzapine in the Treatment of Anorexia Nervosa

This study has been completed.

First Received: January 2, 2008 Last Updated: January 11, 2008 History of Changes

Sponsors and Collaborators:	North Shore Long Island Jewish Health System Eli Lilly and Company
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00592930

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 IV

Drug Information available for: Olanzapine

U.S. FDA Resources

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

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

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:

anorexia nervosa, treatment, adolescents, olanzapine

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Signs and Symptoms, Digestive
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents

Serotonin Uptake Inhibitors
Serotonin
Signs and Symptoms
Mental Disorders
Anorexia
Peripheral Nervous System Agents
Anorexia Nervosa
Eating Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Olanzapine
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Signs and Symptoms
Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Anorexia
Peripheral Nervous System Agents
Anorexia Nervosa
Central Nervous System Agents
Eating Disorders

ClinicalTrials.gov processed this record on May 07, 2009