The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy with olanzapine or risperidone for the treatment of schizophrenia.

Condition	Treatment or Intervention	Phase
Schizophrenia	Drug: Divalproex Sodium Extended-Release Tablets  Drug: Olanzapine  Drug: Risperidone	Phase II

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

KEY INCLUSION CRITERIA

• Acute exacerbation of schizophrenia as defined by: subject recently hospitalized or is in the process of being admitted to a hospital or an acute care inpatient psychiatric treatment facility; and has a PANNS Total score of 70 or greater at the time of screening and at randomization based on a 1-7 point scale; and has a score on any two of the four items from psychoisis cluster of the BPRS (extracted from the PANSS) that correspond to the positive symptoms (hallucinatory behavior, unusual thought content, sonceptual disorganization and suspiciousness) totaling 8 or greater; and has a total of 6 or greater on one of the following two pairs of items from the BPRS (extracted from the PANSS): hostility and uncooperativeness or excitememtn and tension.
• Current DSM-IV-TR diagnosis of schizophrenia as confirmed by the SCID
• Positive response to antipsychotics in the previous 2 years

KEY EXCLUSION CRITERIA

• Current diagnosis of schizoaffective disorder, drug-induced psychosis, manic episode or major depressive episode.
• At the time of screening, has been hospitalized for more than 14 days for the current episode
• Has ever taken clozapine
• Has had more than 3 psychiatric hospitalizations in the previous 6 months or has had more than 8 weeks of psychiatric hospitalization in the previous 12 months
• Has serious violent, homicidal, suicidal ideation
• Has received depot medictions fluphenazine decanoate and/or haloperidon decanoate within 2 or 4 weeks prior to randomization respectively
• Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
• History of alcohol or substance dependence within the past month
• Has taken any valproate product for a psychiatric indication within the previous 30 days
• Has received an investigational drug within the last 30 days

Alabama
      Birmingham,  Alabama,  United States
      Tuscaloosa,  Alabama,  United States
California
      Anaheim,  California,  United States
      Cerritos,  California,  United States
      Chula Vista,  California,  United States
      Garden Grove,  California,  United States
      Glendale,  California,  United States
      Los Angles,  California,  United States
      San Diego,  California,  United States
Colorado
      Denver,  Colorado,  United States
Florida
      Gainsville,  Florida,  United States
      Melbourne,  Florida,  United States
      North Miami,  Florida,  United States
      Winter Park,  Florida,  United States
Georgia
      Atlanta,  Georgia,  United States
Illinois
      Chicago,  Illinois,  United States
      Hoffman Estates,  Illinois,  United States
Indiana
      Indiannapolis,  Indiana,  United States
      South Bend,  Indiana,  United States
Louisiana
      Shreveport,  Louisiana,  United States
Maryland
      Rockville,  Maryland,  United States
Mississippi
      Jackson,  Mississippi,  United States
New Jersey
      Clementon,  New Jersey,  United States
      Kenilworth,  New Jersey,  United States
New York
      Holliswood,  New York,  United States
      New York,  New York,  United States
North Carolina
      Butner,  North Carolina,  United States
Ohio
      Cincinnati,  Ohio,  United States
      Cleveland,  Ohio,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  United States
Texas
      San Antonio,  Texas,  United States
      Austin,  Texas,  United States
      Irving,  Texas,  United States
Virginia
      Falls Church,  Virginia,  United States

Study ID Numbers:  M02-547
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 17, 2003
ClinicalTrials.gov Identifier:  NCT00073164
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08