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Olanzapine in the Treatment of Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
olanzapine
placebo
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring anorexia nervosa, treatment, adolescents, olanzapine

Eligibility Criteria

12 Years - 23 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Females, ages 12-23

Exclusion Criteria:

  • Binge-purge type

Sites / Locations

  • Schneider Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

olanzapine

matching placebo

Outcomes

Primary Outcome Measures

weight gain

Secondary Outcome Measures

measures of psychiatric symptoms

Full Information

First Posted
January 2, 2008
Last Updated
January 11, 2008
Sponsor
Northwell Health
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00592930
Brief Title
Olanzapine in the Treatment of Anorexia Nervosa
Official Title
Pilot Study of the Efficacy of Olanzapine in the Treatment of Anorexias Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Northwell Health
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
anorexia nervosa, treatment, adolescents, olanzapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
olanzapine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Description
flexibly dosed oral olanzapine 2.5 to 15 mg/day
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
weight gain
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
measures of psychiatric symptoms
Time Frame
10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females, ages 12-23 Exclusion Criteria: Binge-purge type
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Kafantaris, M.D.
Organizational Affiliation
Schneider Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21663423
Citation
Kafantaris V, Leigh E, Hertz S, Berest A, Schebendach J, Sterling WM, Saito E, Sunday S, Higdon C, Golden NH, Malhotra AK. A placebo-controlled pilot study of adjunctive olanzapine for adolescents with anorexia nervosa. J Child Adolesc Psychopharmacol. 2011 Jun;21(3):207-12. doi: 10.1089/cap.2010.0139.
Results Reference
derived

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Olanzapine in the Treatment of Anorexia Nervosa

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