6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)

Phase 3

Completed

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

• Registration Number: NCT00265343
• Lead Sponsor: Organon and Co

Brief Summary

This is an extension study 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: 2005-12
• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-14
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Disposition First Submitted: 2009-04-23
• Disposition First Submitted QC: 2009-10-02
• Disposition First Posted: 2009-10-06
• Results First Submitted: 2010-02-17
• Results First Submitted QC: 2010-02-17
• Results First Posted: 2010-02-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• Continue to meet all demographic and procedural

inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into

this extension trial.

• Have demonstrated an acceptable

degree of compliance and completed the 25543

trial, and would benefit from continued treatment

according to the investigator.

Exclusion Criteria

• Have an uncontrolled, unstable clinically significant

medical condition.

• Have been judged to be medically

noncompliant in the management of their disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	asenapine	asenapine
2	olanzapine	olanzapine

Primary Outcome Measures

Name	Time	Method
Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale	Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)	Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 \[best\]-96 \[worst\].

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life Measured by Quality of Life Scale (QLS)	Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)	Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 \[worst\]-126 \[best\].