To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)

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: NCT00150176
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : May 28, 2010
Last Update Posted : October 30, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Asenapine - Open Label Drug: Placebo - Double Blind Drug: Asenapine - Double Blind Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 831 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia
Study Start Date : April 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: asenapine Drug: Asenapine - Open Label
Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).
Other Name: Saphris, Org 5222, SCH 900274
Drug: Asenapine - Double Blind
Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.
Other Name: Org 5222, SCH 900274, Saphris
Placebo Comparator: placebo Drug: Asenapine - Open Label
Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).
Other Name: Saphris, Org 5222, SCH 900274
Drug: Placebo - Double Blind
Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.

Primary Outcome Measures :
  1. Time to Relapse or an Impending Relapse [ Time Frame: time of first relapse up to Day 182 (double blind phase) ]
    A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.

Secondary Outcome Measures :
  1. Time to Early Discontinuation for Any Reason [ Time Frame: time of discontinuation up to Day 182 (double blind phase) ]
    The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Have a primary diagnosis of schizophrenia
  • History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening
  • History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening
  • Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms

Key Exclusion Criteria:

  • Have an uncontrolled, unstable clinically significant medical condition
  • History of suicide attempt or significant violence to others in the past 2 years
  • A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
  • Current substance abuse/dependence
  • Concurrent psychiatric disorder other than schizophrenia.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00150176     History of Changes
Other Study ID Numbers: P05770
First Posted: September 8, 2005    Key Record Dates
Results First Posted: May 28, 2010
Last Update Posted: October 30, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs