To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Asenapine - Open Label; Placebo - Double Blind; Asenapine - Double Blind
Intervention description: 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).; Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.; Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 831.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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.