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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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 ]

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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5. Secondary:

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

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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 ]

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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 ]

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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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 ]

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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16. Secondary:

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

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17. Secondary:

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

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18. Secondary:

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

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19. Secondary:

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

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20. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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 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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

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.

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

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