Clincosm LogoSign in Get a demo

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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00212836
Collaborator
(none)
481
Enrollment
2
Arms
27.4
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
481 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Apr 21, 2005
Actual Primary Completion Date :
Jun 15, 2007
Actual Study Completion Date :
Aug 2, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Asenapine

Drug: asenapine
5-10 mg sublingually twice daily for 26 weeks
Active Comparator: Olanzapine

Drug: olanzapine
5-20 mg by mouth once daily for 26 weeks
Other Names:
  • Zyprexa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes from baseline at 6-months in Negative symptoms of schizophrenia measured by the Negative Symptoms Assessment (NSA) scale [Change from baseline at 6-months]

    Secondary Outcome Measures

    1. Change from baseline at 6-months in quality of life measured by the Quality of Life (QLS) scale [Change from baseline at 6-months]

    2. 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) [Change from baseline at 6-months]

    3. Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS) [Change from baseline at 6-months]

    4. 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) [Change from baseline at 6-months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00212836
    Other Study ID Numbers:
    • P05817
    • Aphrodite;
    • 25543
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Schizophrenia
    Olanzapine
    Asenapine

    Study Results

    No Results Posted as of Feb 16, 2022