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Olanzapine in the Treatment of Patients With Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Dr. Hany Bissada, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00260962
First received: November 30, 2005
Last updated: March 19, 2017
Last verified: March 2017
Results First Received: January 26, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Anorexia Nervosa
Interventions: Drug: Olanzapine
Behavioral: Day Hospital

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible participants were recruited from patients referred to the eating disorders program at The Ottawa Hospital by a family physician or psychiatrist between September 2000 and April 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Plus Day Hospital

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.

Day Hospital: 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 Hospital

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.

Olanzapine: 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.

Day Hospital: 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.


Participant Flow:   Overall Study
    Placebo Plus Day Hospital   Olanzapine Plus Day Hospital
STARTED   18   16 
COMPLETED   14   14 
NOT COMPLETED   4   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Plus Day Hospital

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.

Day Hospital: 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 Hospital

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.

Olanzapine: 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.

Day Hospital: 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.

Total Total of all reporting groups

Baseline Measures
   Placebo Plus Day Hospital   Olanzapine Plus Day Hospital   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   16   34 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.67  (11.59)   23.61  (6.5)   27.03  (9.90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18 100.0%      16 100.0%      34 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Body Mass Index (BMI) (kg/m^2)   [ Time Frame: Baseline (week 2) and post-treatment (week 13) ]

2.  Secondary:   Obsessions   [ Time Frame: Pretreatment (Week 1) and Posttreatment (Week 13) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Hany Bissada
Organization: Ottawa Hospital Research Institute
phone: 613-798-5555 ext 78042
e-mail: hbissada@ottawahospital.on.ca


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Hany Bissada, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00260962     History of Changes
Other Study ID Numbers: 2000210-01H
F1D-CA-O092 ( Other Identifier: Eli Lilly )
Study First Received: November 30, 2005
Results First Received: January 26, 2017
Last Updated: March 19, 2017