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COMPLETEDPHASE3

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

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

NCT00174265•Organon and Co

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Continue to meet all demographic and procedural
•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.

Key Dates

Start Date

July 1, 2005

Primary Completion Date

April 1, 2009

Completion Date

May 1, 2009

Last Updated

February 9, 2022

Enrollment

196

ACTUAL participants

Conditions

Schizophrenia

Interventions

asenapine

DRUG

olanzapine

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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