A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients

May 28, 2009 updated by: Eli Lilly and Company

A Double-Blind Placebo Controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode

Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 4

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

  • United States
    • Florida
      • Hialeah, Florida, United States, 33016
        • 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.

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with a mixed episode of bipolar I disorder.
  • Have had at least one previous manic or mixed episode associated with bipolar disorder
  • You must be between 18 and 60 years old.
  • You must be able to visit the doctor's office three times in the first week and then once every week for the next five weeks.
  • If you are a female, you must have a negative pregnancy test and be using an effective method of contraception.

Exclusion Criteria:

  • You have a diagnosis of schizophrenia, schizoaffective disorder or substance abuse or dependence.
  • You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood.
  • Have required a recent thyroid hormone supplement to treat hypothyroidism (must have been on a stable dose of the medication for at least 2 months prior to Visit 3).
  • You are allergic to any of the medications involved in this study.

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
Experimental: 1
olanzapine and divalproex
Drug: olanzapine
15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
Other Names:
  • Zyprexa
  • LY170053
Drug: divalproex
dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).
Placebo Comparator: 2
placebo and divalproex
Drug: divalproex
dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).
Drug: placebo
placebo, capsules, by mouth every evening, daily, for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.
Time Frame: Baseline to endpoint (6 weeks)
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.
Baseline to endpoint (6 weeks)
Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.
Time Frame: Baseline to endpoint (6 weeks)
The 21-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.
Baseline to endpoint (6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Meeting the Criteria for Mixed Onset of Action
Time Frame: Baseline to endpoint (6 weeks)
The original outcome measure was Time to Mixed Onset of Action (at least a 25% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.
Baseline to endpoint (6 weeks)
Number of Participants Meeting the Criteria for Mixed Response
Time Frame: baseline to endpoint (6 weeks)
The original outcome measure was Time to Mixed Response(at least a 50% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.
baseline to endpoint (6 weeks)
Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint
Time Frame: Baseline to endpoint (6 weeks)
CGI-BP Severity is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Baseline to endpoint (6 weeks)
Number of Patients Hospitalized Due to Relapse of Mania or Depression.
Time Frame: Baseline to endpoint (6 weeks)
Number of participants hospitalized as a result of relapse of mania or depression.
Baseline to endpoint (6 weeks)
Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline
Time Frame: Baseline to endpoint (6 weeks)
Change from Baseline to endpoint in cholesterol: value of cholesterol measure at endpoint minus the value at baseline.
Baseline to endpoint (6 weeks)
Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline
Time Frame: Baseline to endpoint (6 weeks)
Change from baseline to endpoint in triglycerides: Value of triglyceride measure at endpoint minus value at baseline.
Baseline to endpoint (6 weeks)
Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline
Time Frame: Baseline to endpoint (6 weeks)
Change from baseline to endpoint in fasting blood glucose: Value of fasting blood glucose measure at endpoint minus value at baseline.
Baseline to endpoint (6 weeks)
Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline
Time Frame: Baseline to endpoint (6 weeks)
Change from baseline to endpoint in bilirubin total: Value of bilirubin total measure at endpoint minus value at baseline.
Baseline to endpoint (6 weeks)
Clinically Significant Vital Signs - Body Mass Index Change From Baseline
Time Frame: Baseline to endpoint (6 weeks)
Change from baseline to endpoint in body mass index (an estimate of body fat derived by dividing body weight by height squared): Value of body mass index measure at endpoint minus value at baseline.
Baseline to endpoint (6 weeks)
Clinically Significant Vital Signs - Weight Change From Baseline
Time Frame: Baseline to endpoint (6 weeks)
Change from baseline to endpoint: Value of weight measure at endpoint minus value at baseline.
Baseline to endpoint (6 weeks)
Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)
Time Frame: Baseline to endpoint (6 weeks)
Percentages of participants in each group who experienced an increase in weight of at least 7% from baseline to endpoint.
Baseline to endpoint (6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

General Publications

Helpful Links

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

December 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

November 17, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

June 3, 2009

Last Update Submitted That Met QC Criteria

May 28, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10825
  • F1D-US-HGMO

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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