NCT00260962

Brief Summary

The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2000

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

September 1, 2000

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
10.7 years until next milestone

Results Posted

Study results publicly available

April 28, 2017

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

5.8 years

First QC Date

November 30, 2005

Results QC Date

January 26, 2017

Last Update Submit

January 5, 2018

Conditions

Anorexia Nervosa

Keywords

Pilot Project,Clinical Trial,Treatment Outcome,Psychopharmacology

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (BMI) (kg/m^2)

    Body Mass Index (BMI) measured in kg/m\^2 units. Measured at Baseline (week 2) and post-treatment (week 13).

    Baseline (week 2) and post-treatment (week 13)

Secondary Outcomes (1)

  • Obsessions

    Pretreatment (Week 1) and Posttreatment (Week 13)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo and Treatment as usual (Day Hospital Program). After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.

Behavioral: Day Hospital

Olanzapine Plus Day Hospital

EXPERIMENTAL

After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.

Drug: OlanzapineBehavioral: Day Hospital

Interventions

OlanzapineDRUG

After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.

Also known as: Zyprexa
Olanzapine Plus Day Hospital
Day HospitalBEHAVIORAL

Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.

Olanzapine Plus Day HospitalPlacebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • those who meet DSM IV criteria of Anorexia Nervosa- either restricting or binge/purge subtype

You may not qualify if:

  • patients who are actively self destructive and/or suicidal
  • patients whose medical status is seriously compromised
  • patients whose eating disorder is superimposed on a major psychiatric disorder such as schizophrenia, major affective disorders, dissociative disorder or an active substance abuse disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

  • Bissada H, Tasca GA, Barber AM, Bradwejn J. Olanzapine in the treatment of low body weight and obsessive thinking in women with anorexia nervosa: a randomized, double-blind, placebo-controlled trial. Am J Psychiatry. 2008 Oct;165(10):1281-8. doi: 10.1176/appi.ajp.2008.07121900. Epub 2008 Jun 16.

    PMID: 18558642DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

OlanzapinePatient Readmission

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHospitalizationPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Hany Bissada
Organization
Ottawa Hospital Research Institute
hbissada@ottawahospital.on.ca
613-798-5555

Study Officials

  • H Bissada

    OHRI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

September 1, 2000

Primary Completion

July 1, 2006

Study Completion

September 1, 2006

Last Updated

January 30, 2018

Results First Posted

April 28, 2017

Record last verified: 2018-01

Locations

CA(1)