Brief Summary

To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

101

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Feb 2008

Typical duration for phase_3

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

February 1, 2008

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed

12 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed

10 months until next milestone

Results Posted

Study results publicly available

June 27, 2011

Completed

Last Updated

July 27, 2011

Status Verified

July 1, 2011

Enrollment Period

2.6 years

First QC Date

February 8, 2008

Results QC Date

May 24, 2011

Last Update Submit

July 25, 2011

Conditions

Bipolar I Disorder

Keywords

Bipolar

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Adverse Events Leading to Discontinuation
An adverse event (AE) is an untoward medical event associated with the use of the study drug or study procedure, whether or not it is considered related to the study drug or study procedure. Results presented are the percentage of participants who experienced an adverse event that resulted in the discontinuation of the study.
Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)

Secondary Outcomes (11)

Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint
baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
Change From Baseline in Weight at Week 24 or Week 48 Endpoint
baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint
baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint
baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint
baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
+6 more secondary outcomes

Study Arms (3)

Pre-Olanzapine

EXPERIMENTAL

Participants who received olanzapine 5-20 mg/day in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.

Drug: Olanzapine

Pre-Placebo

EXPERIMENTAL

Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.

Drug: Olanzapine

New Olanzapine

EXPERIMENTAL

Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.

Drug: Olanzapine

Interventions

OlanzapineDRUG

5-20 mg/day, oral, daily

Also known as: LY170053

New OlanzapinePre-OlanzapinePre-Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must be aged 18 to less than 75 years.
Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent.
All female patients must test negative for pregnancy.
Females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug.
Male patients who are not surgically sterilized must agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR).
Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode, as defined in the DSM-IV-TR.
Patients must have a current Young Mania Rating Scale (YMRS) Total score =\<8.

You may not qualify if:

Is investigator site personnel directly affiliated with this study or their immediate families.
Is a Lilly employee.
Has previously completed or withdrawn from this study or any other study investigating olanzapine.
Is pregnant or nursing.
Has a serious, unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (10)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Aichi, 470-1168, Japan

Location

Chiba, 270-1694, Japan

Location

Hiroshima, 731-0501, Japan

Location

Kanagawa, 231-0027, Japan

Location

Kyoto, 616-8421, Japan

Location

Numakunai, 023-0801, Japan

Location

Saitama, 332-0012, Japan

Location

Shiga, 525-0037, Japan

Location

Tokyo, 170-0002, Japan

Location

Yamaguchi, 755-8505, Japan

Location

Related Publications (1)

Katagiri H, Tohen M, McDonnell DP, Fujikoshi S, Case M, Kanba S, Takahashi M, Gomez JC. Safety and efficacy of olanzapine in the long-term treatment of Japanese patients with bipolar I disorder, depression: an integrated analysis. Psychiatry Clin Neurosci. 2014 Jul;68(7):498-505. doi: 10.1111/pcn.12156. Epub 2014 Mar 4.
PMID: 24417745DERIVED

MeSH Terms

Interventions

Olanzapine

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4599) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 20, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

July 27, 2011

Results First Posted

June 27, 2011

Record last verified: 2011-07

Locations

JP(10)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (3)

Pre-Olanzapine

Pre-Placebo

New Olanzapine

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (3)

Pre-Olanzapine

Pre-Placebo

New Olanzapine

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations