Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00129220

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder	Drug: olanzapine Drug: haloperidol Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To confirm the superiority of olanzapine versus placebo in improving the severity of the manic symptoms, as measured by the Young Mania Rating Scale, associated with bipolar I disorder. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare olanzapine to haloperidol in improving overall bipolar symptomatology as measured by the Young Mania Rating Scale, Hamilton Depression Scale - 17 item version and Clinical Global Impressions - Bipolar Version, Severity of Illness. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of olanzapine on overall manic symptomatology (both depression and mania) in comparison to placebo and haloperidol as measured by changes in the Clinical Global Impression - Bipolar Version, Severity of Illness. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of olanzapine on manic symptoms in comparison to placebo and haloperidol as measured by remission of mania according to the Young Mania Rating Scale. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of olanzapine on depressive symptoms in comparison to placebo and haloperidol as measured by the Hamilton Depression Scale - 17 item version. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of olanzapine on psychotic symptoms in comparison to placebo and haloperidol as measured by changes in the Positive Subscore of Positive and Negative Syndrome Scale. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
To evaluate switch-to-depression between therapies; defined as a shift from a Manic Episode at baseline to a Major Depressive Episode after randomization, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	224
Study Start Date:	July 2005
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental olanzapine	Drug: olanzapine 5-20mg, oral, once daily (evening), for 6 weeks
B: Active Comparator haloperidol	Drug: haloperidol 2.5-10mg, oral, twice daily (morning and evening), for 6 weeks.
C: Placebo Comparator placebo	Drug: placebo placebo, oral tablets, twice daily (morning and evening), for 3 weeks

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet the criteria for manic or mixed episodes according to the 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 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129220

Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hokkaido, Japan, 004-0841

Sponsors and Collaborators

Eli Lilly and Company

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9636, F1D-JE-BMAC
Study First Received:	August 8, 2005
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00129220 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eli Lilly and Company:

Manic or mixed episode associated with bipolar I disorder

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Haloperidol
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Disease
Tranquilizing Agents

Bipolar Disorder
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Haloperidol decanoate
Serotonin Agents
Autonomic Agents
Mood Disorders
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010