Status:

COMPLETED

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

Lead Sponsor:

Organon and Co

Collaborating Sponsors:

Pfizer

Conditions:

Bipolar Disorder

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 i...

Eligibility Criteria

Inclusion

  • 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

  • Patients with unstable medical conditions or clinically significant laboratory
  • abnormalities.

Key Trial Info

Start Date :

July 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2007

Estimated Enrollment :

218 Patients enrolled

Trial Details

Trial ID

NCT00159783

Start Date

July 1 2005

End Date

April 1 2007

Last Update

February 9 2022

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