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Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00266630
First received: December 15, 2005
Last updated: December 10, 2010
Last verified: December 2010
Results First Received: May 26, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Manic or Mixed Episode Associated With Bipolar I Disorder
Interventions: Drug: olanzapine
Drug: lithium
Drug: valproate
Drug: carbamazepine

  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 Monotherapy Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine + Mood Stabilizer Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.

Participant Flow:   Overall Study
    Olanzapine Monotherapy     Olanzapine + Mood Stabilizer  
STARTED     100     39  
COMPLETED     58     11  
NOT COMPLETED     42     28  
Adverse Event                 8                 6  
Lack of Efficacy                 1                 4  
Entry Criteria not met                 1                 0  
Protocol Violation                 1                 3  
Physician Decision                 1                 2  
Withdrawal by Subject                 10                 2  
Lost to Follow-up                 1                 0  
Not Specified                 19                 11  



  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 Monotherapy Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine + Mood Stabilizer Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Total Total of all reporting groups

Baseline Measures
    Olanzapine Monotherapy     Olanzapine + Mood Stabilizer     Total  
Number of Participants  
[units: participants]
  100     39     139  
Age  
[units: years]
Mean ± Standard Deviation
  41.8  ± 11.7     43.2  ± 11.1     42.2  ± 11.6  
Gender  
[units: participants]
     
Female     59     21     80  
Male     41     18     59  
Race/Ethnicity, Customized  
[units: participants]
     
Japanese     100     39     139  
Region of Enrollment  
[units: participants]
     
Japan     100     39     139  
Current Episode - Mixed or Manic [1]
[units: participants]
     
Manic     88     39     127  
Mixed     12     0     12  
Current Episode - Psychotic or Nonpsychotic [1]
[units: participants]
     
Psychotic     13     9     22  
Nonpsychotic     87     30     117  
Rapid Cyclers [2]
[units: participants]
     
Rapid Cyclers     7     3     10  
Non-Rapid Cyclers     93     36     129  
Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) overall [3]
[units: units on a scale]
Mean ± Standard Deviation
  1.9  ± 1.0     4.7  ± 0.8     2.7  ± 1.6  
Hamilton Depression Scale - 17 item version (HAMD-17) Total Score [4]
[units: units on a scale]
Mean ± Standard Deviation
  1.8  ± 3.1     4.4  ± 3.9     2.5  ± 3.5  
Length of Current Episode  
[units: days]
Mean ± Standard Deviation
  33.5  ± 23.9     35.0  ± 26.7     33.9  ± 24.6  
Mean Age at Onset of Illness  
[units: years]
Mean ± Standard Deviation
  31.5  ± 11.6     29.8  ± 8.4     31.0  ± 10.8  
Young Mania Rating Scale (YMRS) Total Score [5]
[units: units on a scale]
Mean ± Standard Deviation
  5.7  ± 6.4     33.2  ± 6.6     13.4  ± 13.9  
[1] Description of the bipolar episode the participant experienced when enrolling into the study.
[2] A rapid cycler is defined as a person who experiences four or more mood swings or episodes in a twelve-month period.
[3] Measures severity of the patient's overall severity of bipolar symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
[4] The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
[5] The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.



  Outcome Measures
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1.  Primary:   Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only   [ Time Frame: baseline through 18 weeks ]

2.  Primary:   Number of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only   [ Time Frame: baseline through 18 weeks ]

3.  Primary:   Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only   [ Time Frame: baseline through 18 weeks ]

4.  Primary:   Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only   [ Time Frame: baseline through 18 weeks ]

5.  Secondary:   Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer Only   [ Time Frame: baseline through 18 weeks ]

6.  Secondary:   Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data   [ Time Frame: baseline, Weeks 1, 2, 4, 6, 10, 14, 18 ]

7.  Secondary:   Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17)   [ Time Frame: baseline through 18 weeks ]

8.  Secondary:   Number of Participants With Relapse of Depressive Symptoms   [ Time Frame: baseline through 18 weeks ]

9.  Secondary:   Number of Participants Who Experienced Remission of Bipolar Disorder   [ Time Frame: Week 18 ]

10.  Secondary:   Positive and Negative Syndrome Scale Positive Scores - Visit Data   [ Time Frame: baseline, Weeks 1, 2, 4, 6, 10, 14, 18 ]

11.  Secondary:   Number of Participants Who Switched to Syndromic Depression   [ Time Frame: baseline through 18 weeks ]

12.  Secondary:   Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score   [ Time Frame: baseline through 18 weeks ]

13.  Secondary:   Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores   [ Time Frame: baseline through 18 weeks ]

14.  Secondary:   Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores   [ Time Frame: baseline through 18 weeks ]

15.  Secondary:   Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores   [ Time Frame: baseline through 18 weeks ]

16.  Secondary:   Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores   [ Time Frame: baseline through 18 weeks ]

17.  Secondary:   Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes   [ Time Frame: baseline through 18 weeks ]

18.  Secondary:   Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight   [ Time Frame: baseline through 18 weeks ]

19.  Secondary:   Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF)   [ Time Frame: baseline through 18 weeks ]

20.  Secondary:   Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values   [ Time Frame: baseline through 18 weeks ]


  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
Identified errors were corrected.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00266630     History of Changes
Other Study ID Numbers: 9637, F1D-JE-BMEX
Study First Received: December 15, 2005
Results First Received: May 26, 2010
Last Updated: December 10, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare