9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)

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

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-07

Study Completion Date

2006-06-28

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. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Asenapine

Group Type EXPERIMENTAL

Asenapine

Intervention Type DRUG

Asenapine , 9 weeks

2

Olanzapine

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

Olanzapine, 9 weeks

Interventions

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Asenapine

Asenapine , 9 weeks

Intervention Type DRUG

Olanzapine

Olanzapine, 9 weeks

Intervention Type DRUG

Other Intervention Names

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Org 5222

Eligibility Criteria

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Inclusion Criteria

* Have completed an asenapine 3-week study for the treatment of an acute manic or mixed episode and not had a major protocol violation.in the short term study (A7501004 or A7501005) that they completed.