Olanzapine in the Treatment of Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Pilot Study of the Efficacy of Olanzapine in the Treatment of Anorexias Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592930
• Other study ID #: 99-04-072
• Secondary ID: Lilly F1D-US-X16
• Status: Completed
• Phase: Phase 4
• First received: January 2, 2008
• Last updated: January 11, 2008
• Start date: June 2000
• Est. completion date: December 2004

Study information

• Verified date: January 2008
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 23 Years

Eligibility

Inclusion Criteria:

• Females, ages 12-23

Exclusion Criteria:

• Binge-purge type

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Drug:
• olanzapine
flexibly dosed oral olanzapine 2.5 to 15 mg/day
• placebo

Locations

Country	Name	City	State
United States	Schneider Children's Hospital	New Hyde Park	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain		10 weeks	No
Secondary	measures of psychiatric symptoms		10 weeks	No