The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.

Condition	Treatment or Intervention	Phase
Schizophrenia	Drug: SM-13496	Phase II

Further Study Details: 

Expected Total Enrollment:  330

Ages Eligible for Study:  18 Years   -   64 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• The patient has a primary diagnosis of schizophrenia
• The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
• The patient has had a duration of illness of at least one year.
• The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
• The patient is able to remain off antipsychotic medication for a 4 day washout period

Exclusion criteria:

• The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.
• The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/mL at baseline
• Pregnancy

California
      Optimum Health Services, La Mesa,  California,  91942,  United States
      Sharp Mesa Vista Hospital, San Diego,  California,  92123,  United States
      Institute for Psychopharmacology Research, Cerritos,  California,  90703,  United States
      Affiliated Research Institute, San Diego,  California,  92108,  United States
District of Columbia
      Comprehensive Neuroscience. Inc., Washington,  District of Columbia,  20016,  United States
Florida
      Comprehensive Neuroscience. Inc., Melbourne,  Florida,  32935,  United States
      Segal Institute for Clinical Research, North Miami,  Florida,  33161,  United States
Georgia
      Atlanta Center for Medical Research, Atlanta,  Georgia,  30308,  United States
      Carman Research, Smyrna,  Georgia,  30080,  United States
Hawaii
      Hawaii Research Center, Honolulu,  Hawaii,  96826,  United States
Illinois
      American Medical Research, Oakbrook,  Illinois,  60523,  United States
Maryland
      Centers for Behavioral Health, LLC, Rockville,  Maryland,  20850,  United States
New Jersey
      ClinSearch, Inc., Kenilworth,  New Jersey,  07033,  United States
      Comprehensive Clinical Research CNS, PC, Clementon,  New Jersey,  08021,  United States
Pennsylvania
      Quantum Clinical Services Group, Philadelphia,  Pennsylvania,  19139,  United States
Texas
      FutureSearch Trials, Austin,  Texas,  78756,  United States
      Community Clinical Research, Austin,  Texas,  78756,  United States
      University Hills Clinical Research, Dallas,  Texas,  75235,  United States
      Claghorn Lesem Research Clinic, Inc., Bellaire,  Texas,  77401,  United States
Virginia
      CNS, Inc., Falls Church,  Virginia,  22041,  United States
Washington
      Northwest Clinical Research Center, Belleview,  Washington,  98004,  United States

Study ID Numbers:  D1050049
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  August 16, 2002
ClinicalTrials.gov Identifier:  NCT00044044
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08