Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846) (ACTAMESA)

Organon

Status and phase: Completed; Phase 3

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: asenapine; Drug: olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00212771

P05846

25520

Details and patient eligibility

About

The primary features of schizophrenia and schizoaffective disorder are positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving maintaining productive employment.

Asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject with schizophrenia or schizoaffective disorder. Must have completed 12 months treatment under protocol 25517. Subject must sign a written informed consent.

Exclusion criteria

• Have an uncontrolled, unstable, clinically significant medical condition.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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440 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: asenapine

Arm 2

Active Comparator group

Treatment:

Drug: olanzapine