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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
asenapine
olanzapine
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Asenapine

    Olanzapine

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Change from baseline at 6-months in quality of life measured by the Quality of Life (QLS) scale
    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)
    Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS)
    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)

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00212836
    Brief Title
    Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 21, 2005 (Actual)
    Primary Completion Date
    June 15, 2007 (Actual)
    Study Completion Date
    August 2, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    481 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Asenapine
    Arm Type
    Experimental
    Arm Title
    Olanzapine
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    asenapine
    Intervention Description
    5-10 mg sublingually twice daily for 26 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    olanzapine
    Other Intervention Name(s)
    Zyprexa
    Intervention Description
    5-20 mg by mouth once daily for 26 weeks
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS)
    Time Frame
    Change from baseline at 6-months
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22198451
    Citation
    Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

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

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