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Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
University of Pittsburgh
Johns Hopkins University
University of Toronto
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01170117
First received: July 23, 2010
Last updated: August 24, 2017
Last verified: August 2017
Results First Received: February 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anorexia Nervosa
Interventions: Drug: Olanzapine
Drug: Placebo

  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
Recruitment took place from December 2010 through June 2016 at each of the five study sites, which are medical clinics: Columbia University-New York State Psychiatric Institute, Weill Cornell Medical College, Centre For Addiction And Mental Health in Toronto, University Of Pittsburgh and Johns Hopkins University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 25 individuals across sites discontinued the trial prior to group assignment, and 17 were withdrawn by investigators before randomization. These individuals were excluded from the trial due to various reasons such desiring alternate care, and not being interested in medication.

Reporting Groups
  Description
Placebo

Control group receiving placebo

Placebo: Control Group will receive placebo pill.

Olanzapine

Group receiving olanzapine

Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.


Participant Flow:   Overall Study
    Placebo   Olanzapine
STARTED   77   75 
COMPLETED   47   55 
NOT COMPLETED   30   20 



  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

Control group receiving placebo

Placebo: Control Group will receive placebo pill

Olanzapine

Group receiving olanzapine

Olanzapine: Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.

Total Total of all reporting groups

Baseline Measures
   Placebo   Olanzapine   Total 
Overall Participants Analyzed 
[Units: Participants]
 77   75   152 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.0  (10.9)   28.0  (10.8)   29.0  (10.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      75  97.4%      71  94.7%      146  96.1% 
Male      2   2.6%      4   5.3%      6   3.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      6   7.8%      8  10.7%      14   9.2% 
Not Hispanic or Latino      71  92.2%      67  89.3%      138  90.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      5   6.5%      5   6.7%      10   6.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   1.3%      1   1.3%      2   1.3% 
White      71  92.2%      69  92.0%      140  92.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
 16.69  (1.18)   16.79  (1.17)   16.7  (1.20) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Weight Change   [ Time Frame: Weekly during 16-week trial and twice during 8 weeks follow-up ]

2.  Primary:   Psychological Change   [ Time Frame: Weekly during 16-week intervention and twice during 8-week follow-up ]


  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. Evelyn Attia
Organization: Columbia Center for Eating Disorders
phone: 646-774-8085
e-mail: ea12@cumc.columbia.edu


Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01170117     History of Changes
Other Study ID Numbers: #6142/7117R
R01MH085921 ( U.S. NIH Grant/Contract )
Study First Received: July 23, 2010
Results First Received: February 14, 2017
Last Updated: August 24, 2017