Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Haloperidol; Asenapine; Asenapine
Intervention description: 2-8 mg BID; 5 or 10 mg BID; 5 or 10 mg BID
Intervention MeSH terms: Haloperidol; Haloperidol decanoate; Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by
      Positive symptoms (symptoms that should not be there, inability to think clearly, to
      distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or
      absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and
      relate to others). Other symptoms include reduced ability to recall and learn new
      information, difficulty with problem solving, or maintaining productive employment. 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.

      The clinical development of asenapine, as described in the 2007 IDB appears to have
      antipsychotic activity with superior symptomatic control compared to placebo and an improved
      safety profile compared to currently available neuroleptics. Its fast dissolving formulation
      may further add to treatment compliance. While various titration schedules have been used in
      previous studies, dose increases at 5 mg BID (twice daily) up to 10 mg BID have been well
      tolerated. Therefore, further exploration in a larger group of subjects with acute
      exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID)
      will mimic actual clinical practice in a long-term 52-week extension trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the short-term 041023 trial (NCT00156104)

          -  Continued to meet all demographic and procedural inclusion criteria of the short-term
             trial upon entry into this long-term extension trial

          -  Sign a written informed consent for the 041513 trial.

          -  Demonstrated an acceptable degree of compliance with trial medication in the
             short-term trials in the opinion of the investigator

        Exclusion Criteria:

          -  CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or
             equal to 6 (severely psychotic)

          -  Occurrence(s) of AEs (adverse events) or other clinically significant findings that
             would prohibit their continuation

          -  Met any of exclusion criteria regarding medical/psychiatric status listed in the
             041023 short-term trial

          -  Met exclusion criteria for medication status in short-term trials except for
             antidepressants and mood stabilizers.