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

Organon and Co440 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

440

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in total PANSS score at endpoint

Time frame: Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint

Secondary Outcomes

Changes in PANSS subscale scores and Marder factor scores

Time frame: Every 24 weeks after baseline

Changes in CGI-S

Time frame: Every 12 weeks after baseline

Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)

Time frame: Every 48 weeks after baseline

Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)

Time frame: Every 24 weeks after baseline

Resource utilization (as measured by frequency and length of hospital stay)

Time frame: During the entire study period

Safety and tolerability: EPS (AIMS, BARS, SARS)

Time frame: Every 24 weeks after baseline

Adverse Events

Time frame: Continuously and up to 7 days after endpoint

Pregnancy Test

Time frame: At endpoint

Blood Tests

Time frame: Every 12 weeks after baseline

Weight and vital signs

Time frame: Every 4 weeks after baseline

ECGs

Time frame: Every 24 weeks after baseline