Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed

This study has been completed.

Study NCT00618748 Information provided by Eli Lilly and Company

First Received on February 8, 2008. Last Updated on July 25, 2011 History of Changes

Results First Received: May 24, 2011

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:	Bipolar I Disorder
Intervention:	Drug: Olanzapine

Participant Flow

Hide Participant Flow

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
Pre-Olanzapine	Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
Pre-Placebo	Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
New Olanzapine	Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.

Participant Flow: Overall Study

	Pre-Olanzapine	Pre-Placebo	New Olanzapine
STARTED	56	25	20
COMPLETED	45	20	6
NOT COMPLETED	11	5	14
Adverse Event	4	3	8
Physician Decision	3	1	1
Withdrawal by Subject	4	1	5

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Pre-Olanzapine	Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
Pre-Placebo	Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
New Olanzapine	Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.

Baseline Measures

	Pre-Olanzapine	Pre-Placebo	New Olanzapine	Total
Number of Participants [units: participants]	56	25	20	101
Age [units: years] Mean ± Standard Deviation	39.31 ± 10.48	37.53 ± 7.64	39.13 ± 9.56	38.84 ± 9.61
Gender [units: participants]
Female	34	14	13	61
Male	22	11	7	40
Race/Ethnicity, Customized [units: participants]
East Asian	56	25	20	101
Region of Enrollment [units: participants]
Japan	56	25	20	101
Montgomery- Asberg Depression Rating Scale (MADRS) Total Score ^[1] [units: units on a scale] Mean ± Standard Deviation	8.05 ± 7.50	9.72 ± 6.48	16.45 ± 9.03	10.13 ± 8.18
Young Mania Rating Scale (YMRS) Total Score ^[2] [units: units on a scale] Mean ± Standard Deviation	0.38 ± 1.10	0.40 ± 0.76	0.45 ± 0.83	0.40 ± 0.97
Clinical Global Improvement- Bipolar (CGI-BP) - Mania ^[3] [units: units on a scale] Mean ± Standard Deviation	1.09 ± 0.35	1.00 ± 0.00	1.00 ± 0.00	1.05 ± 0.26
CGI-BP - Depression ^[4] [units: units on a scale] Mean ± Standard Deviation	2.23 ± 0.95	2.48 ± 0.82	3.55 ± 1.15	2.55 ± 1.08
CGI-BP - Overall ^[5] [units: units on a scale] Mean ± Standard Deviation	2.20 ± 0.92	2.40 ± 0.82	3.25 ± 1.02	2.46 ± 1.00

[1]	The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
[2]	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.
[3]	CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The Mania score ranges from 1 (normal, not ill) to 7 (very seriously ill).
[4]	CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The Depression score ranges from 1 (normal, not ill) to 7 (very seriously ill).
[5]	CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The Overall Illness score ranges from 1 (normal, not ill) to 7 (very seriously ill).

Outcome Measures

Show All Outcome Measures

1. Primary:

Percentage of Participants With Adverse Events Leading to Discontinuation [ Time Frame: Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint [ Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in Weight at Week 24 or Week 48 Endpoint [ Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint [ Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint [ Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint [ Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 6

7. Secondary:

Percentage of Participants With Emergence of Mania at Week 24 or Week 48 [ Time Frame: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 7

8. Secondary:

Percentage of Participants With High Suicidality at Week 24 or Week 48 [ Time Frame: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 8

9. Secondary:

Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48 [ Time Frame: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 9

10. Secondary:

Change From Baseline in Hemoglobin (HbA1c) at Week 24 or Week 48 Endpoint [ Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 10

11. Secondary:

Change From Baseline in Prolactin at Week 24 or Week 48 Endpoint [ Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 11

12. Secondary:

Change From Baseline to in QTcF at Week 24 or Week 48 Endpoint [ Time Frame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine) ]

Show Outcome Measure 12

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

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:	NCT00618748 History of Changes
Other Study ID Numbers:	11682, F1D-JE-HGMS
Study First Received:	February 8, 2008
Results First Received:	May 24, 2011
Last Updated:	July 25, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare