Olanzapine in the Treatment of Anorexia Nervosa

NCT ID: NCT00592930

Last Updated: 2008-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2004-12-31

Brief Summary

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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

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Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

olanzapine

Group Type EXPERIMENTAL

olanzapine

Intervention Type DRUG

flexibly dosed oral olanzapine 2.5 to 15 mg/day

2

matching placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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olanzapine

flexibly dosed oral olanzapine 2.5 to 15 mg/day

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females, ages 12-23

Exclusion Criteria

* Binge-purge type
Minimum Eligible Age

12 Years

Maximum Eligible Age

23 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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North Shore- Long Island Jewish Health System

Principal Investigators

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Vivian Kafantaris, M.D.

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Hospital

Locations

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Schneider Children's Hospital

New Hyde Park, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21663423 (View on PubMed)

Other Identifiers

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Lilly F1D-US-X166

Identifier Type: -

Identifier Source: secondary_id

99-04-072

Identifier Type: -

Identifier Source: org_study_id

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