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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar I Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

olanzapine and divalproex

Group Type EXPERIMENTAL

olanzapine

Intervention Type DRUG

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).

divalproex

Intervention Type DRUG

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).

2

placebo and divalproex

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo, capsules, by mouth every evening, daily, for 6 weeks.

divalproex

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

placebo

placebo, capsules, by mouth every evening, daily, for 6 weeks.

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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LY170053 Zyprexa

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No