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 maintain 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. Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6-month study that will test the efficacy and safety of Asenapine and a comparator agent in the treatment of patients with schizophrenia. Patients that complete the first 6-month study wil have the option of continuing in an additional 6-month extension study.

Condition	Intervention	Phase
Schizophrenia	Drug: Asenapie  Drug: Active Comparator	Phase III

Further Study Details: 

Primary Outcomes: Improvement in symptoms of schizophrenia at 6-months
Expected Total Enrollment:  444

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype.
• No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
• Caregiver required.

Exclusion Criteria:

• Have an uncontrolled, unstable clinically significant medical condition.
• Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.

Please refer to this study by ClinicalTrials.gov identifier  NCT00145496

Pfizer CT.gov Call Center      1-800-718-1021 

California
      Pfizer Investigational Site, Torrance,  California,  90505,  United States; Recruiting
      Pfizer Investigational Site, National City,  California,  91950,  United States; Recruiting
      Pfizer Investigational Site, Santa Ana,  California,  92705,  United States; Recruiting
      Pfizer Investigational Site, San Diego,  California,  92123,  United States; Recruiting
      Pfizer Investigational Site, Oceanside,  California,  92056,  United States; Recruiting
      Pfizer Investigational Site, Pico Rivera,  California,  90660,  United States; Recruiting
      Pfizer Investigational Site, San Diego,  California,  92108,  United States; Recruiting
      Pfizer Investigational Site, Anaheim,  California,  92805,  United States; No longer recruiting
      Pfizer Investigational Site, Culver City,  California,  90232,  United States; Recruiting
      Pfizer Investigational Site, Garden Grove,  California,  92845,  United States; Recruiting
      Pfizer Investigational Site, Long Beach,  California,  90807,  United States; Recruiting
District of Columbia
      Pfizer Investigational Site, Washington,  District of Columbia,  20016,  United States; Recruiting
Florida
      Pfizer Investigational Site, Melbourne,  Florida,  32901,  United States; Recruiting
      Pfizer Investigational Site, Melbourne,  Florida,  32935,  United States; Recruiting
      Pfizer Investigational Site, North Miami,  Florida,  33161,  United States; Recruiting
      Pfizer Investigational Site, Hialeah,  Florida,  33016,  United States; Recruiting
      Pfizer Investigational Site, Tampa,  Florida,  33613,  United States; Recruiting
      Pfizer Investigational Site, Ft. Lauderdale,  Florida,  33308,  United States; Recruiting
      Pfizer Investigational Site, Ft. Lauderdale,  Florida,  33319,  United States; Recruiting
      Pfizer Investigational Site, North Miami,  Florida,  33161,  United States; Recruiting
Georgia
      Pfizer Investigational Site, Marietta,  Georgia,  30060,  United States; Recruiting
Hawaii
      Pfizer Investigational Site, Honolulu,  Hawaii,  96826,  United States; Recruiting
Illinois
      Pfizer Investigational Site, Hoffman Estates,  Illinois,  60194,  United States; Recruiting
Louisiana
      Pfizer Investigational Site, Shreveport,  Louisiana,  71101,  United States; Recruiting
      Pfizer Investigational Site, Lake Charles,  Louisiana,  70601,  United States; Recruiting
Maryland
      Pfizer Investigational Site, Glen Burnie,  Maryland,  21061,  United States; Recruiting
Michigan
      Pfizer Investigational Site, Detroit,  Michigan,  48201,  United States; Recruiting
Mississippi
      Pfizer Investigational Site, Flowood,  Mississippi,  39232,  United States; Recruiting
      Pfizer Investigational Site, Flowood,  Mississippi,  39232,  United States; Recruiting
Missouri
      Pfizer Investigational Site, St. Louis,  Missouri,  63118,  United States; Recruiting
Nevada
      Pfizer Investigational Site, Las Vegas,  Nevada,  89102,  United States; Recruiting
New Jersey
      Pfizer Investigational Site, Clementon,  New Jersey,  08021,  United States; Recruiting
      Pfizer Investigational Site, Runnemede,  New Jersey,  08078,  United States; Recruiting
New Mexico
      Pfizer Investigational Site, Albuquerque,  New Mexico,  87102,  United States; Recruiting
      Pfizer Investigational Site, Albuquerque,  New Mexico,  87112,  United States; Recruiting
      Pfizer Investigational Site, Albuquerque,  New Mexico,  87108,  United States; Recruiting
New York
      Pfizer Investigational Site, Staten Island,  New York,  10305,  United States; Recruiting
      Pfizer Investigational Site, New York,  New York,  10027,  United States; Recruiting
      Pfizer Investigational Site, New York,  New York,  10035,  United States; Recruiting
      Pfizer Investigational Site, Brooklyn,  New York,  11235,  United States; Recruiting
      Pfizer Investigational Site, Brooklyn,  New York,  11203,  United States; Recruiting
Ohio
      Pfizer Investigational Site, Dayton,  Ohio,  45408,  United States; Recruiting
Pennsylvania
      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19131,  United States; Recruiting
      Pfizer Investigational Site, Norristown,  Pennsylvania,  19401,  United States; Recruiting
      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19139,  United States; Recruiting
Texas
      Pfizer Investigational Site, Houston,  Texas,  77057,  United States; Recruiting
      Pfizer Investigational Site, Austin,  Texas,  78756,  United States; Recruiting
      Pfizer Investigational Site, Dallas,  Texas,  75240,  United States; Recruiting
      Pfizer Investigational Site, Irving,  Texas,  75062,  United States; Recruiting
      Pfizer Investigational Site, Bellaire,  Texas,  77401,  United States; Recruiting
      Pfizer Investigational Site, Houston,  Texas,  77008,  United States; Recruiting
      Pfizer Investigational Site, DeSots,  Texas,  75115,  United States; Recruiting
Canada, Quebec
      Pfizer Investigational Site, Montreal,  Quebec,  H1N 3M5,  Canada; Recruiting
      Pfizer Investigational Site, Montreal,  Quebec,  H3A 1A1,  Canada; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A7501013
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145496
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06