The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.

Condition	Treatment or Intervention	Phase
Bipolar Disorder	Drug: Divalproex Sodium Extended-Release Tablets	Phase III

Further Study Details: 

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

Criteria

KEY INCLUSION CRITERIA

• Current primary diagnosis of bipolar I disorder, mania or mixed type
• Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score >= 18
• Hospitalized no more than 7 days at time of Screening or in process of being admitted
• History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement

KEY EXCLUSION CRITERIA

• History of schizophrenia or schizoaffective disorder
• Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
• Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteriods)
• Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania)
• Had first manic episode after age 60
• Has ever taken clozapine
• Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug
• Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
• History of active alcohol or substance dependence within past 3 months.
• History of failed treatment on adequate valproate therapy for bipolar disorder
• Has taken Depakote (DR or ER) regularly over the last 30 days
• Has serious violent, homicidal, or suicidal ideation

California
      Comprehensive Neuroscience of SCA, Cerritos,  California,  90703,  United States
      AVI Clinical Research, Torrance,  California,  90505,  United States
District of Columbia
      Washington Hospital Center, Washington,  District of Columbia,  20010,  United States
Illinois
      Mark Lerman, MD, Hoffman Estates,  Illinois,  60194,  United States
Kentucky
      University of Louisville Bipolar Research Program, Louisville,  Kentucky,  40202,  United States
Louisiana
      Brentwood Research Inst., Shreveport,  Louisiana,  71101,  United States
Maryland
      Centers for Behavioral Health, LLC, Rockville,  Maryland,  20850,  United States
Massachusetts
      McLean Hospital, Belmont,  Massachusetts,  02478,  United States
Michigan
      Pioneer Research, Baltimore,  Michigan,  48047,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216,  United States
New Jersey
      Steven A. Glass, MD, Clementon,  New Jersey,  08021,  United States
New York
      The Holliswood Hospital, Holliswood,  New York,  11423,  United States
      NYU School of Medicine – Bellevue, New York,  New York,  10016,  United States
Ohio
      MetroHealth Medical Center, Cleveland,  Ohio,  44109,  United States
Texas
      UT Mental Sciences Institute, Houston,  Texas,  77030,  United States
      San Antonio State Hospital, San Antonio,  Texas,  78223,  United States
Virginia
      CNS of Northern Virginia, Falls Church,  Virginia,  22041,  United States
Wisconsin
      VAMC, Milwaukee,  Wisconsin,  53295,  United States

Study ID Numbers:  M02-540
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  May 15, 2003
ClinicalTrials.gov Identifier:  NCT00060905
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08