COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00212836
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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
Schizophrenia Drug: asenapine Drug: olanzapine Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : April 21, 2005
Actual Primary Completion Date : June 15, 2007
Actual Study Completion Date : August 2, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: Zyprexa

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Publications of Results:
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00212836    
Other Study ID Numbers: P05817
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents