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: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Asenapine - Open Label
Drug: Placebo - Double Blind
Drug: Asenapine - Double Blind
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 831
Study Start Date: April 2005
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00150176     History of Changes
Other Study ID Numbers: P05770, A7501012
Study First Received: September 2, 2005
Results First Received: April 28, 2010
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Asenapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014