Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)

February 7, 2022 updated by: Organon and Co

A Multicenter, Double-Blind, Flexible -Dose, 6-Month Trial Comparing the Efficacy Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia

Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, have shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

481

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
  • No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
  • Caregiver required.

Exclusion Criteria:

  • Have an uncontrolled, unstable clinically significant medical condition.
  • Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Olanzapine
Drug: olanzapine
5-20 mg by mouth once daily for 26 weeks
Other Names:
  • Zyprexa
Experimental: Asenapine
Drug: asenapine
5-10 mg sublingually twice daily for 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline at 6-months in Negative symptoms of schizophrenia measured by the Negative Symptoms Assessment (NSA) scale
Time Frame: Change from baseline at 6-months
Change from baseline at 6-months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline at 6-months in quality of life measured by the Quality of Life (QLS) scale
Time Frame: Change from baseline at 6-months
Change from baseline at 6-months
Positive and negative symptoms and other symptoms of schizophrenia e.g., hostility, excitement, disorganized thoughts and cognition measured by the Positive and Negative Symptom Scale (PANSS)
Time Frame: Change from baseline at 6-months
Change from baseline at 6-months
Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame: Change from baseline at 6-months
Change from baseline at 6-months
Overall clinical global impression of severity improvement measured by the Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I)
Time Frame: Change from baseline at 6-months
Change from baseline at 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2005

Primary Completion (Actual)

June 15, 2007

Study Completion (Actual)

August 2, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05817
  • Aphrodite;
  • 25543

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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