40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-04-30

Brief Summary

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Bipolar disorder is characterized by mood swings that range from 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. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.

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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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Asenapine

Asenapine 5-10 mg twice daily for 40 weeks

Group Type EXPERIMENTAL

asenapine

Intervention Type DRUG

Asenapine, 40 weeks

Olanzapine

Olanzapine 5-20 mg once daily for 40 weeks

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

Olanzapine, 40 weeks

Interventions

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asenapine

Asenapine, 40 weeks

Intervention Type DRUG

Olanzapine

Olanzapine, 40 weeks

Intervention Type DRUG

Other Intervention Names

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Org 5222

Eligibility Criteria

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Inclusion Criteria

* Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..