Completed

NCT Number: NCT00174265

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

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.

Completed

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

asenapine

Drug

5-10 mg sublingually twice daily for 26 weeks

Olanzapine

Drug

5-20 mg by mouth once daily for 26 weeks

Other names: Zyprexa

Primary outcomes

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

Time frame: 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 outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed Protocol A7501013

Important dates

Study start: 2005
Primary completion: 2009
Study completion: 2009
First posted: Sep 15, 2005
Registry last updated: Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed