Clinical trial NCT00618748: Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed
Official title: Safety and Efficacy of Olanzapine (LY170053) in the Long-term Treatment for Patients With Bipolar I Disorder, Depressed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Keywords: Bipolar
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (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 (NCT#00510146) and patients who did not participate in Study HGMP who have been recruited to participate in Study HGMS.

Eligibility criteria: Inclusion Criteria:

1. Patients must be aged 18 to less than 75 years.
2. 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.
3. All female patients must test negative for pregnancy.
4. 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.
5. 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.
6. 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).
7. 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.
8. Patients must have a current Young Mania Rating Scale (YMRS) Total score =\<8.

Exclusion Criteria:

1. Is investigator site personnel directly affiliated with this study or their immediate families.
2. Is a Lilly employee.
3. Has previously completed or withdrawn from this study or any other study investigating olanzapine.
4. Is pregnant or nursing.
5. 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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events Leading to Discontinuation
timeFrame: Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
Secondary outcomes:
measure: Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint
timeFrame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
measure: Change From Baseline in Weight at Week 24 or Week 48 Endpoint
timeFrame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint
timeFrame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
measure: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint
timeFrame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
measure: Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint
timeFrame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
measure: Percentage of Participants With Emergence of Mania at Week 24 or Week 48
timeFrame: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
measure: Percentage of Participants With High Suicidality at Week 24 or Week 48
timeFrame: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
measure: Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48
timeFrame: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
measure: Change From Baseline in Hemoglobin (HbA1c) at Week 24 or Week 48 Endpoint
timeFrame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
measure: Change From Baseline in Prolactin at Week 24 or Week 48 Endpoint
timeFrame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
measure: Change From Baseline to in QTcF at Week 24 or Week 48 Endpoint
timeFrame: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: 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.
city: Chiba
country: Japan
facility: 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.
city: Hiroshima
country: Japan
facility: 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.
city: Iwate
country: Japan
facility: 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.
city: Kanagawa
country: Japan
facility: 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.
city: Kyoto
country: Japan
facility: 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.
city: Saitama
country: Japan
facility: 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.
city: Shiga
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: 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.
city: Yamaguchi
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.