Olanzapine vs. Comparator and Placebo in the Treatment of Patients With Bipolar I Disorder
NCT ID: NCT00094549
Last Updated: 2007-01-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
500 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-10-31
Study Completion Date
2006-12-31
Brief Summary
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The goals of this study are:
A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania.
B. To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine.
C. To assess how olanzapine compares to divalproex.
A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania.
B. To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine.
C. To assess how olanzapine compares to divalproex.
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Detailed Description
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Conditions
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Bipolar Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Interventions
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olanzapine
Intervention Type
DRUG
divalproex sodium
Intervention Type
DRUG
placebo
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* You must be 18 to 65 years old.
* You must have a diagnosis of bipolar I disorder and must be experiencing a manic or mixed (symptoms of mania and depression occurring together) episode.
* You must be able to visit the doctor's office as scheduled for 15 weeks.
* All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.
* You must have a diagnosis of bipolar I disorder and must be experiencing a manic or mixed (symptoms of mania and depression occurring together) episode.
* You must be able to visit the doctor's office as scheduled for 15 weeks.
* All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.
Exclusion Criteria
* You have rapid cycling bipolar disorder, or are having hallucinations or delusions, or are feeling suicidal.
* You are pregnant or breastfeeding
* You have a history of: inadequately controlled diabetes; heart disease; narrow angle glaucoma; low white blood cell or platelet count; have a positive test result for human immunodeficiency virus (HIV+); or any other serious, unstable illnesses as judged by the study physician.
* You are pregnant or breastfeeding
* You have a history of: inadequately controlled diabetes; heart disease; narrow angle glaucoma; low white blood cell or platelet count; have a positive test result for human immunodeficiency virus (HIV+); or any other serious, unstable illnesses as judged by the study physician.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Principal Investigators
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Call1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Scottsdale, Arizona, United States
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Beverly Hills, California, United States
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Pico Rivera, California, United States
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Joliet, Illinois, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Charlottesville, Virginia, United States
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Virginia Beach, Virginia, United States
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Charleston, West Virginia, United States
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Ziegzdriu K, , Lithuania
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Caguas, , Puerto Rico
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Bucharest, , Romania
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Lipetsk, , Russia
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Saint Petersburg, , Russia
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Countries
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United States
Lithuania
Puerto Rico
Romania
Russia
References
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Houston JP, Kohler J, Bishop JR, Ellingrod VL, Ostbye KM, Zhao F, Conley RR, Poole Hoffmann V, Fijal BA. Pharmacogenomic associations with weight gain in olanzapine treatment of patients without schizophrenia. J Clin Psychiatry. 2012 Aug;73(8):1077-86. doi: 10.4088/JCP.11m06916.
Reference Type
DERIVED
Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20.
Reference Type
DERIVED
Tohen M, Vieta E, Goodwin GM, Sun B, Amsterdam JD, Banov M, Shekhar A, Aaronson ST, Bardenstein L, Grecu-Gabos I, Tochilov V, Prelipceanu D, Oliff HS, Kryzhanovskaya L, Bowden C. Olanzapine versus divalproex versus placebo in the treatment of mild to moderate mania: a randomized, 12-week, double-blind study. J Clin Psychiatry. 2008 Nov;69(11):1776-89. doi: 10.4088/jcp.v69n1113. Epub 2008 Oct 7.
Reference Type
DERIVED
Other Identifiers
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F1D-MC-HGKQ
Identifier Type: -
Identifier Source: secondary_id
7029
Identifier Type: -
Identifier Source: org_study_id
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