Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

500

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Oct 2004

Typical duration for phase_4

Geographic Reach

5 countries

42 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Start

First participant enrolled

October 1, 2004

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2004

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2004

Completed

2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed

Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

October 20, 2004

Last Update Submit

January 24, 2007

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

To test the superiority of olanzapine compared with divalproex in improving overall manic symptomatology in patients with mild to moderate
mania associated with bipolar I disorder, as measured by reductions on the Young Mania Rating Scale (YMRS) total score from baseline to the endpoint of Study Period II (3-week acute therapy phase).

Secondary Outcomes (31)

Treatment comparison for the reductions of the YMRS total score from baseline to the endpoint of Study Period II: Assess the superiority of olanzapine compared to placebo;
Assess the superiority of divalproex compared to placebo;
In the event that olanzapine vs. divalproex comparison is not significant, and that divalproex is superior to placebo, an assessment of non-inferiority of olanzapine compared with divalproex will be performed
Assess the acute efficacy of olanzapine compared with divalproex and placebo in improving clinical symptomatology during Study Period II, using several measures: Rate of response, with response defined as reduction of
50% or more in the YMRS total score at the endpoint of Study Period II; Time to response, with time to response defined as the time in days from first dose at which a reduction of 50% or more in the YMRS total score is first
+26 more secondary outcomes

Interventions

olanzapineDRUG

divalproex sodiumDRUG

placeboDRUG

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (42)

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. test

Scottsdale, Arizona, 85251, United States

Location

Beverly Hills, California, 90211, United States

Location

Costa Mesa, California, 92626, United States

Location

Escondido, California, 92025, United States

Location

Orange, California, 92868, United States

Location

Pico Rivera, California, 90660, United States

Location

San Diego, California, 92108, United States

Location

Washington D.C., District of Columbia, 20016, United States

Location

Boyton Beach, Florida, 33426, United States

Location

DeLand, Florida, 32720, United States

Location

North Miami, Florida, 33161, United States

Location

Tampa, Florida, 33613, United States

Location

Decatur, Georgia, 30033, United States

Location

Marietta, Georgia, 30060, United States

Location

Eagle, Idaho, 83616, United States

Location

Chicago, Illinois, 60631, United States

Location

Joliet, Illinois, 60435, United States

Location

Wichita, Kansas, 67207, United States

Location

Baltimore, Maryland, 21285, United States

Location

Brooklyn, New York, 11223, United States

Location

Buffalo, New York, 14215, United States

Location

Rochester, New York, 14624, United States

Location

Oklahoma City, Oklahoma, 73120, United States

Location

Media, Pennsylvania, 19063, United States

Location

Memphis, Tennessee, 38119, United States

Location

Austin, Texas, 78756, United States

Location

Dallas, Texas, 74234, United States

Location

Charlottesville, Virginia, 22903, United States

Location

Virginia Beach, Virginia, 23452, United States

Location

Bellevue, Washington, 98004, United States

Location

Charleston, West Virginia, 25301, United States

Location

Klaipėda, 91251, Lithuania

Location

Šiauliai, 76231, Lithuania

Location

Vilnius, 11205, Lithuania

Location

Ziegzdriu K, 53136, Lithuania

Location

Caguas, 00725, Puerto Rico

Location

Ponce, 00731, Puerto Rico

Location

Bucharest, 050042, Romania

Location

Târgu Mureş, 540139, Romania

Location

Lipetsk, 399007, Russia

Location

Moscow, 107076, Russia

Location

Saint Petersburg, 190021, Russia

Location

Related Publications (3)

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.
PMID: 22967772DERIVED
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.
PMID: 21095016DERIVED
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.
PMID: 19014751DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

OlanzapineValproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

October 20, 2004

First Posted

October 21, 2004

Study Start

October 1, 2004

Study Completion

December 1, 2006

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

RO(2)RU(3)US(31)PR(2)LI(4)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (31)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (42)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations