- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00129220
Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
December 10, 2010 updated by: Eli Lilly and Company
Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
224
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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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.
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Akita, Japan, 010-1654
- 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.
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Chiba, Japan, 283-0062
- 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.
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Fukuoka, Japan, 807-8555
- 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.
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Gunma, Japan, 370-2455
- 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.
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Hokkaido, Japan, 004-0841
- 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.
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Hyogo, Japan, 663-8501
- 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.
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Kanagawa, Japan, 236-0037
- 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.
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Kumamoto, Japan, 861-0002
- 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.
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Nagano, Japan, 384-8540
- 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.
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Okayama, Japan, 700-8558
- 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.
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Okinawa, Japan, 904-2222
- 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.
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Osaka, Japan, 561-0803
- 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.
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Saga, Japan, 842-0192
- 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.
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Saitama, Japan, 343-0032
- 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.
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Tokyo, Japan, 160-0023
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed".
- Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.
Exclusion Criteria:
- Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.
- The duration of the current episode is more than 90 days at Visit 1.
- Have a history or a diagnosis of diabetes mellitus.
- Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Olanzapine
olanzapine: 5 to 20 mg per day for 6 weeks
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5-20 mg, oral, once daily (evening), for 6 weeks
Other Names:
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Active Comparator: Haloperidol
haloperidol: 2.5 to 10 mg per day for 6 weeks
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2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks.
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Placebo Comparator: Placebo
placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
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placebo, oral tablets, twice daily (morning and evening), for 3 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score
Time Frame: Baseline, 3 weeks
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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.
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Baseline, 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)
Time Frame: Baseline, 6 weeks
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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.
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Baseline, 6 weeks
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Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)
Time Frame: 6 weeks
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Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe).
The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe).
Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.
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6 weeks
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Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness
Time Frame: Baseline, 6 weeks
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A global rating scale for severity of patients adapted to bipolar disorder.
Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
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Baseline, 6 weeks
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Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale
Time Frame: Baseline, 3 weeks, 6 weeks
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A global rating scale for severity of patients adapted to bipolar disorder.
Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
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Baseline, 3 weeks, 6 weeks
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Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks
Time Frame: Baseline, 3 weeks, 6 weeks
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Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder.
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. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100.
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Baseline, 3 weeks, 6 weeks
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Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks
Time Frame: 3 weeks, 6 weeks
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Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms.
YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe).
Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.
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3 weeks, 6 weeks
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Percentage of Participants Who Switched to Symptomatic Depression
Time Frame: 3 weeks, 6 weeks
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Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline.
The 17-item HAMD measures depression severity.
Each item was evaluated and scored using either a 5-point scale (e.g.
absent, mild, moderate, severe, very severe) or a 3-point scale (e.g.
absent, mild, marked).
The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
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3 weeks, 6 weeks
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Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)
Time Frame: Baseline, 3 weeks, 6 weeks
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Assesses positive symptoms associated with schizophrenia.
7 items make up the Positive scale (ex.
delusions, conceptual disorganization, and hallucinatory behavior).
Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe).
Total Positive Subscale scores range from 7 to 49.
For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.
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Baseline, 3 weeks, 6 weeks
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Percentage of Participants Who Switched to Syndromic Depression
Time Frame: 3 weeks, 6 weeks
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Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR).
The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR.
Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6).
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3 weeks, 6 weeks
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Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score
Time Frame: Baseline to 6 weeks
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Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment.
Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe).
The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe).
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Baseline to 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
August 8, 2005
First Submitted That Met QC Criteria
August 8, 2005
First Posted (Estimate)
August 11, 2005
Study Record Updates
Last Update Posted (Estimate)
December 28, 2010
Last Update Submitted That Met QC Criteria
December 10, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Bipolar and Related Disorders
- Disease
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Dopamine Agents
- Dopamine Antagonists
- Anti-Dyskinesia Agents
- Olanzapine
- Haloperidol
- Haloperidol decanoate
Other Study ID Numbers
- 9636
- F1D-JE-BMAC (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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