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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 15, 2007

Interventions

  • Drug: asenapine
    • 5-10 mg sublingually twice daily for 26 weeks
  • Drug: olanzapine
    • 5-20 mg by mouth once daily for 26 weeks

Arms, Groups and Cohorts

  • Experimental: Asenapine
  • Active Comparator: Olanzapine

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS)
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

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.

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