6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)

Phase 3

Completed

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

• Registration Number: NCT00174265
• Lead Sponsor: Organon and Co

Brief Summary

This is an extension study of A7501013 (P05771/NCT00145496) to further test

the efficacy and safety of Asenapine compared with a

marketed agent (olanzapine) in the treatment of patients with

persistent negative symptoms of schizophrenia.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Disposition First Submitted: 2009-06-09
• Disposition First Submitted QC: 2009-10-02
• Disposition First Posted: 2009-10-06
• Results First Submitted: 2010-05-27
• Results First Submitted QC: 2010-05-27
• Results First Posted: 2010-07-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Continue to meet all demographic and procedural

inclusion criteria of the A7501013 trial to enter into

this extension trial.

• Have demonstrated an acceptable degree of compliance

and completed the A7501013 trial, and would benefit

from continued treatment according to the investigator.

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Exclusion Criteria

• Have an uncontrolled, unstable clinically significant

medical condition.

• Have been judged to be medically noncompliant in the

management of their disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
asenapine	asenapine	-
olanzapine	olanzapine	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score	Baseline of A7501013 to Day 365	The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score	Baseline of A7501013 to Day 365	The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life.