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

Organon and Co196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

196

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 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. 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

Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score

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.

Time frame: Baseline of A7501013 to Day 365

Secondary Outcomes

Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score

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.

Time frame: Baseline of A7501013 to Day 365

Data from ClinicalTrials.gov

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