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

Phase 3

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: asenapine; Drug: olanzapine

• Registration Number: NCT00212771
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-09
• Study Completion: 2006-10
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	asenapine	-
Arm 2	olanzapine	-

Primary Outcome Measures

Name	Time	Method
Change in total PANSS score at endpoint	Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint

Secondary Outcome Measures

Name	Time	Method
Changes in PANSS subscale scores and Marder factor scores	Every 24 weeks after baseline
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)	Every 48 weeks after baseline
Resource utilization (as measured by frequency and length of hospital stay)	During the entire study period
Changes in CGI-S	Every 12 weeks after baseline
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)	Every 24 weeks after baseline
Weight and vital signs	Every 4 weeks after baseline
Adverse Events	Continuously and up to 7 days after endpoint
Safety and tolerability: EPS (AIMS, BARS, SARS)	Every 24 weeks after baseline
Pregnancy Test	At endpoint
Blood Tests	Every 12 weeks after baseline
ECGs	Every 24 weeks after baseline