Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00618748
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : June 27, 2011
Last Update Posted : July 27, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Olanzapine Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Olanzapine (LY170053) in the Long-term Treatment for Patients With Bipolar I Disorder, Depressed
Study Start Date : February 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pre-Olanzapine
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
5-20 mg/day, oral, daily
Other Name: LY170053

Experimental: Pre-Placebo
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
Drug: Olanzapine
5-20 mg/day, oral, daily
Other Name: LY170053

Experimental: New Olanzapine
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
Drug: Olanzapine
5-20 mg/day, oral, daily
Other Name: LY170053




Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
    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).

  4. 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) ]
    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.

  5. 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) ]
    CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The scores for mania, depression, and overall illness each range from 1 (normal, not ill) to 7 (very seriously ill).

  6. 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) ]
    Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. 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.

  7. 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) ]
    The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17).

  8. 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) ]
    EPS symptoms measured by DIEPSS are grouped into 4 categories: Parkinsonism, akathisia, dystonia, and dyskinesia. Severity ranges from level 0 (none, normal) to 4 (severe). A participant is deemed to have EPS at endpoint if they have an abnormal endpoint. Normal baseline Parkinsonism is defined as a score not ≥3 on 1 item or ≥2 on 2 items; abnormal endpoint is a score ≥3 on 1 item or ≥2 on 2 items, or an increase of 3 on Parkinsonism total. Normal baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score ≥2 or an increase ≥2 from that baseline score.

  9. 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) ]
    HbA1c is a test that measures the amount of glycated hemoglobin in the blood over prolonged periods of time.

  10. 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) ]
  11. 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) ]
    Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618748


Locations
Layout table for location information
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.
Aichi, Japan, 470-1168
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.
Chiba, Japan, 270-1694
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.
Hiroshima, Japan, 731-0501
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.
Iwate, Japan, 023-0801
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.
Kanagawa, Japan, 231-0027
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.
Kyoto, Japan, 616-8421
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.
Saitama, Japan, 332-0012
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.
Shiga, Japan, 525-0037
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.
Tokyo, Japan, 170-0002
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.
Yamaguchi, Japan, 755-8505
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00618748     History of Changes
Other Study ID Numbers: 11682
F1D-JE-HGMS ( Other Identifier: Eli Lilly and Company )
First Posted: February 20, 2008    Key Record Dates
Results First Posted: June 27, 2011
Last Update Posted: July 27, 2011
Last Verified: July 2011

Keywords provided by Eli Lilly and Company:
Bipolar

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Pathologic Processes
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents