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OpenTrials
Completed

NCT Number: NCT00212836

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

asenapine

Drug

5-10 mg sublingually twice daily for 26 weeks

Olanzapine

Drug

5-20 mg by mouth once daily for 26 weeks

Other names: Zyprexa

Primary outcomes

  1. 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 outcomes

  1. 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

  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)

    Time frame: Change from baseline at 6-months

  3. Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS)

    Time frame: 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)

    Time frame: Change from baseline at 6-months

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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