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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00150176
First received: September 2, 2005
Last updated: October 23, 2014
Last verified: October 2014

September 2, 2005
October 23, 2014
April 2005
June 2008   (final data collection date for primary outcome measure)
Time to Relapse or an Impending Relapse [ Time Frame: time of first relapse up to Day 182 (double blind phase) ] [ Designated as safety issue: No ]
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.
Improvement in time to relapse in schizophrenic population
Complete list of historical versions of study NCT00150176 on ClinicalTrials.gov Archive Site
Time to Early Discontinuation for Any Reason [ Time Frame: time of discontinuation up to Day 182 (double blind phase) ] [ Designated as safety issue: No ]
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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To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)
A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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.
  • 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
  • Experimental: asenapine
    Interventions:
    • Drug: Asenapine - Open Label
    • Drug: Asenapine - Double Blind
  • Placebo Comparator: placebo
    Interventions:
    • Drug: Asenapine - Open Label
    • Drug: Placebo - Double Blind
Kane JM, Mackle M, Snow-Adami L, Zhao J, Szegedi A, Panagides J. A randomized placebo-controlled trial of asenapine for the prevention of relapse of schizophrenia after long-term treatment. J Clin Psychiatry. 2011 Mar;72(3):349-55. doi: 10.4088/JCP.10m06306. Epub 2011 Feb 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
831
July 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00150176
P05770, A7501012
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP