Phase 3 Completed N=196 Quadruple-blind Treatment

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

Schizophrenia

Source: ClinicalTrials.gov NCT00174265 ↗

Enrolled (actual)

196

Serious AEs

4.1%

Results posted

Jul 2010

Primary outcomePrimary: Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score — 61.5; 60.3; -15.8; -11.0 Units on a Scale — p=0.0148

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score	61.5; 60.3; -15.8; -11.0	0.0148 sig
SECONDARY Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score	45.3; 42.3; 12.4; 11.7	0.8100

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00174265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.