3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

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

PHASE3

Total Enrollment

489 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-14

Study Completion Date

2006-04-28

Brief Summary

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Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. This is a 3-week study that will test the safety and efficacy of this medication. Participants will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Participants will be required to stay in the hospital for at least the first seven days of treatment. Participants who complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Asenapine

Group Type EXPERIMENTAL

Asenapine

Intervention Type DRUG

Asenapine, 3 weeks

Arm 2

Olanzapine

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

Olanzapine, 3 weeks

Arm 3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo, 3 weeks

Interventions

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Asenapine

Asenapine, 3 weeks

Intervention Type DRUG

Olanzapine

Olanzapine, 3 weeks

Intervention Type DRUG

Placebo

placebo, 3 weeks

Intervention Type DRUG

Other Intervention Names

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Org 5222

Eligibility Criteria

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Inclusion Criteria

* Have a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.

Exclusion Criteria

* Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder as a primary diagnosis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No