NCT00692185

Brief Summary

This study will evaluate the effectiveness of the antipsychotic medication olanzapine in treating outpatients with anorexia nervosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_2

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

October 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 17, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 10, 2019

Status Verified

April 1, 2019

Enrollment Period

4.9 years

First QC Date

June 4, 2008

Results QC Date

May 28, 2009

Last Update Submit

April 18, 2019

Conditions

Eating Disorders

Keywords

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

  • Weight Gain

    Measured at Week 8

Secondary Outcomes (1)

  • Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale

    Measured at Week 8

Study Arms (2)

1

EXPERIMENTAL

Participants will take olanzapine.

Drug: Olanzapine

2

PLACEBO COMPARATOR

Participants will take matched placebo.

Drug: Placebo

Interventions

OlanzapineDRUG

Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.

Also known as: zyprexa
1
PlaceboDRUG

Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV criteria (not including amenorrhea) for AN
  • Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2
  • Patient (or family if the patient is a minor) refuses hospitalization
  • Free of psychotropic medication (4 weeks medication free for fluoxetine and antipsychotic medication; 2 weeks medication free for all others) OR on a stable dose of an SSRI or SNRI (venlafaxine) for 4 weeks before study entry
  • Prior treatment of AN

You may not qualify if:

  • Any medical or psychiatric problem requiring urgent attention and/or any significant comorbid illness not likely to benefit from proposed treatments
  • Allergy to olanzapine
  • Significant orthostatic high blood pressure
  • Recent commencement of psychotherapy in the community
  • Diabetes mellitus, with a fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose greater than 140 mg/dL
  • Known history of current or past jaundice
  • Known history of narrow angle glaucoma
  • Active substance abuse or dependence
  • Schizophrenia, schizophreniform disorder, or bipolar illness
  • Movement disorder or presence of tics
  • History of tardive dyskinesia
  • History of seizures
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eating Disorders Clinic, New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • Attia E, Kaplan AS, Walsh BT, Gershkovich M, Yilmaz Z, Musante D, Wang Y. Olanzapine versus placebo for out-patients with anorexia nervosa. Psychol Med. 2011 Oct;41(10):2177-82. doi: 10.1017/S0033291711000390. Epub 2011 Mar 22.

    PMID: 21426603DERIVED

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia Nervosa

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Evelyn Attia, MD
Organization
New York State Psychiatric Institute
ea12@columbia.edu
212-543-5923

Study Officials

  • Evelyn Attia, MD

    New York State Psychiatric Institute at Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

October 1, 2005

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 10, 2019

Results First Posted

July 17, 2009

Record last verified: 2019-04

Locations

US(1)