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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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