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

Organon and Co306 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

306

Conditions

Schizophrenia

Interventions

asenapineDRUG

5-10 mg sublingually twice daily for 26 weeks

olanzapineDRUG

5-20 mg by mouth once daily for 26 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale

Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 \[best\]-96 \[worst\].

Time frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)

Secondary Outcomes

Change in Quality of Life Measured by Quality of Life Scale (QLS)

Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 \[worst\]-126 \[best\].

Time frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)

Data from ClinicalTrials.gov

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