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

Organon

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Olanzapine; Drug: asenapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00159783

A7501007

P05857

Details and patient eligibility

About

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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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..

Exclusion criteria

• Patients with unstable medical conditions or clinically significant laboratory

abnormalities.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups

Asenapine

Experimental group

Description:

Asenapine 5-10 mg twice daily for 40 weeks

Treatment:

Drug: asenapine

Olanzapine

Active Comparator group

Description:

Olanzapine 5-20 mg once daily for 40 weeks

Treatment:

Drug: Olanzapine