Olanzapine in the Treatment of Anorexia Nervosa | NCT00592930

Studies
Olanzapine in the Treatment of Anorexia Nervosa

NCT00592930

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Jan 14, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Anorexia Nervosa

Interventions

olanzapine
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Lilly F1D-US-X166

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2000

Primary Completion Date

Dec 2004Actual

Completion Date

Dec 2004

First Submitted Date

Jan 2, 2008

First Submission Date that Met QC Criteria

Jan 11, 2008

First Posted Date

Jan 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2008

Last Update Posted Date

Jan 14, 2008Estimated

Name	Class
Eli Lilly and Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	olanzapine	Drug: olanzapine
2	Placebo Comparator	matching placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
olanzapine	Drug	flexibly dosed oral olanzapine 2.5 to 15 mg/day	1

Measure	Description	Time Frame
weight gain		10 weeks

Measure	Description	Time Frame
measures of psychiatric symptoms		10 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females, ages 12-23

Exclusion Criteria:

Binge-purge type

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

23 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vivian Kafantaris, M.D.	Schneider Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schneider Children's Hospital		New Hyde Park	New York	11040	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21663423	Derived	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.

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring