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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00618748 |
To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.
Condition | Intervention | Phase |
---|---|---|
Bipolar I Disorder |
Drug: Olanzapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Olanzapine (LY170053) in the Long-Term Treatment for Patients With Bipolar I Disorder, Depressed |
Estimated Enrollment: | 100 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Olanzapine
5-20mg/day,oral,daily,48weeks
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This is an open-label, multi-center, long-term treatment study conducted only in Japanese sites. The subjects are patients who fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the DSM-IV-TR (296.50=unspecified, 296.52=moderate severity, 296.53=severe without psychotic features, 296.54=severe with psychotic features), who have completed Study HGMP and patients who did not participate in Study HGMP who have been recruited to participate in Study HGMS.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
Japan | |
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. | Not yet recruiting |
Hiroshima, Japan, 731-0501 | |
Contact: Eli Lilly | |
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. | Not yet recruiting |
Chiba, Japan, 270-1694 | |
Contact: Eli Lilly | |
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. | Not yet recruiting |
Shiga, Japan, 525-0037 | |
Contact: Eli Lilly | |
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. | Not yet recruiting |
Osaka, Japan, 543-0056 | |
Contact: Eli Lilly | |
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. | Not yet recruiting |
Iwate, Japan, 023-0801 | |
Contact: Eli Lilly | |
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. | Recruiting |
Yamaguchi, Japan, 755-8505 | |
Contact: Eli Lilly | |
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. | Recruiting |
Saitama, Japan, 332-0012 | |
Contact: Eli Lilly | |
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. | Recruiting |
Kyoto, Japan, 616-8421 | |
Contact: Eli Lilly | |
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. | Recruiting |
Tokyo, Japan, 170-0002 | |
Contact: Eli Lilly | |
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. | Recruiting |
Aichi, Japan, 470-1168 | |
Contact: Eli Lilly | |
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. | Not yet recruiting |
Kanagawa, Japan, 231-0027 | |
Contact: Eli Lilly |
Study Director: | 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 |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 11682, F1D-JE-HGMS |
Study First Received: | February 8, 2008 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00618748 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Bipolar |
Depression Olanzapine Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |