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Short Term Rescue Study of Olanzapine

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Terrence Ketter, Stanford University
ClinicalTrials.gov Identifier:
NCT00186017
First received: September 12, 2005
Last updated: April 12, 2017
Last verified: April 2017
Results First Received: December 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Intervention: Drug: Olanzapine/Zyprexa

  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
No text entered.

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
Olanzapine/Zyprexa

Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week

Olanzapine/Zyprexa

Placebo

Placebo

Olanzapine/Zyprexa


Participant Flow:   Overall Study
    Olanzapine/Zyprexa   Placebo
STARTED   25   25 
COMPLETED   23   22 
NOT COMPLETED   2   3 



  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
Olanzapine/Zyprexa

Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week

Olanzapine/Zyprexa

Placebo

Placebo

Olanzapine/Zyprexa

Total Total of all reporting groups

Baseline Measures
   Olanzapine/Zyprexa   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   22   45 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.1  (12)   42.9  (9.9)   40.8  (11.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  34.8%      6  27.3%      14  31.1% 
Male      15  65.2%      16  72.7%      31  68.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/Ethnicity       
White      17  73.9%      13  59.1%      30  66.7% 
Non-White      6  26.1%      9  40.9%      15  33.3% 
Region of Enrollment 
[Units: Participants]
     
United States   23   22   45 
Bipolar Subtype 
[Units: Participants]
     
Bipolar 1   12   11   23 
Bipolar 2   11   7   18 
Bipolar NOS   0   4   4 
CGI-BP_OS [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.8  (.8)   4.7  (.8)   4.8  (.8) 
[1]

Clinical Global Impressions-Bipolar Version-Overall Severity of Illness (CGI-BP-OS) Scale is 0-7 0=not Assessed

1=Normal 7=Worst



  Outcome Measures
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1.  Primary:   Mean Change in CGI-BP-OS After 1 Week of Treatment   [ Time Frame: Baseline, 1 Week ]

2.  Secondary:   Mean Change in YMRS After 1 Week of Treatment   [ Time Frame: Baseline, 1 week ]

3.  Secondary:   Mean Change in MADRS After 1 Week of Treatment.   [ Time Frame: Baseline, 1 week ]

4.  Secondary:   Mean Change in Hamilton Anxiety Rating Scales (HAM-A)   [ Time Frame: Baseline, 1 Week ]


  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
Small Sample Size.


  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. Terence A. Ketter, MD.
Organization: Stanford University School of Medicine
phone: 6507232507
e-mail: tketter@stanford.edu



Responsible Party: Terrence Ketter, Stanford University
ClinicalTrials.gov Identifier: NCT00186017     History of Changes
Other Study ID Numbers: 79897
F1D-US-X279 ( Other Grant/Funding Number: Eli Lilly )
Study First Received: September 12, 2005
Results First Received: December 21, 2016
Last Updated: April 12, 2017