NCT00592930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
Last Updated

January 14, 2008

Status Verified

January 1, 2008

Enrollment Period

4.5 years

First QC Date

January 2, 2008

Last Update Submit

January 11, 2008

Conditions

Anorexia Nervosa

Keywords

anorexia nervosa, treatment, adolescents, olanzapine

Outcome Measures

Primary Outcomes (1)

  • weight gain

    10 weeks

Secondary Outcomes (1)

  • measures of psychiatric symptoms

    10 weeks

Study Arms (2)

1

EXPERIMENTAL

olanzapine

Drug: olanzapine

2

PLACEBO COMPARATOR

matching placebo

Drug: placebo

Interventions

olanzapineDRUG

flexibly dosed oral olanzapine 2.5 to 15 mg/day

1
placeboDRUG
2

Eligibility Criteria

Age12 Years - 23 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Females, ages 12-23

You may not qualify if:

  • Binge-purge type

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Hospital

New Hyde Park, New York, 11040, United States

Location

Related Publications (1)

  • 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.

    PMID: 21663423DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Vivian Kafantaris, M.D.

    Schneider Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 14, 2008

Study Start

June 1, 2000

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

January 14, 2008

Record last verified: 2008-01

Locations

US(1)