The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

Condition	Treatment or Intervention	Phase
Bipolar Disorder	Drug: Aripiprazole	Phase III

Further Study Details: 

Expected Total Enrollment:  290

Ages Eligible for Study:  10 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features

Exclusion Criteria:

• Patients with certain other psychological disorders
• Patients with a co-morbid serious, uncontrolled systemic illness
• Patients with significant risk of committing suicide

Please refer to this study by ClinicalTrials.gov identifier  NCT00110461

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Arizona
      Local Institution, Scottsdale,  Arizona,  United States; Not yet recruiting
Arkansas
      Local Institution, Little Rock,  Arkansas,  United States; Recruiting
      Local Institution, Little Rock,  Arkansas,  United States; Not yet recruiting
California
      Local Institution, Escondido,  California,  United States; Not yet recruiting
      Local Institution, Riverside,  California,  United States; Recruiting
      Local Institution, Sacramento,  California,  United States; Not yet recruiting
      Local Institution, San Diego,  California,  United States; Not yet recruiting
      Local Institution, Stanford,  California,  United States; Not yet recruiting
      Local Institution, Pasadena,  California,  United States; Not yet recruiting
District of Columbia
      Local Institution, Washington,  District of Columbia,  United States; Not yet recruiting
      Local Institution, Washington,  District of Columbia,  United States; Recruiting
Florida
      Local Institution, Altamonte Springs,  Florida,  United States; Recruiting
      Local Institution, Hialeah,  Florida,  United States; Not yet recruiting
      Local Institution, Jacksonville,  Florida,  United States; Not yet recruiting
      Local Institution, Miami,  Florida,  United States; Not yet recruiting
      Local Institution, North Miami,  Florida,  United States; Not yet recruiting
      Local Institution, Tampa,  Florida,  United States; Not yet recruiting
Georgia
      Local Institution, Atlanta,  Georgia,  United States; Not yet recruiting
Idaho
      Local Institution, Boise,  Idaho,  United States; Recruiting
Illinois
      Local Institution, Chicago,  Illinois,  United States; Not yet recruiting
      Local Institution, Libertyville,  Illinois,  United States; Recruiting
Indiana
      Local Institution, Indianapolis,  Indiana,  United States; Not yet recruiting
Kansas
      Local Institution, Kansas City,  Kansas,  United States; Not yet recruiting
Kentucky
      Local Institution, Lexington,  Kentucky,  United States; Not yet recruiting
Louisiana
      Local Institution, Lake Charles,  Louisiana,  United States; Recruiting
      Local Institution, New Orleans,  Louisiana,  United States; Not yet recruiting
      Local Institution, Shreveport,  Louisiana,  United States; Not yet recruiting
Massachusetts
      Local Institution, Cambridge,  Massachusetts,  United States; Not yet recruiting
      Local Institution, Somerville,  Massachusetts,  United States; Not yet recruiting
Michigan
      Local Institution, Clinton Township,  Michigan,  United States; Recruiting
      Local Institution, Rochester Hills,  Michigan,  United States; Not yet recruiting
Missouri
      Local Institution, Kansas City,  Missouri,  United States; Not yet recruiting
      Local Institution, St. Louis,  Missouri,  United States; Not yet recruiting
Nevada
      Local Institution, Las Vegas,  Nevada,  United States; Recruiting
New York
      Local Institution, Elmsford,  New York,  United States; Not yet recruiting
      Local Institution, New York,  New York,  United States; Not yet recruiting
      Local Institution, Rochester,  New York,  United States; Not yet recruiting
      Local Institution, Stony Brook,  New York,  United States; Not yet recruiting
Ohio
      Local Institution, Cleveland,  Ohio,  United States; Not yet recruiting
Oklahoma
      Local Institution, Oklahoma City,  Oklahoma,  United States; Recruiting
Pennsylvania
      Local Institution, Bala Cynwyd,  Pennsylvania,  United States; Recruiting
      Local Institution, Philadelphia,  Pennsylvania,  United States; Not yet recruiting
South Carolina
      Local Institution, Charleston,  South Carolina,  United States; Not yet recruiting
Texas
      Local Institution, Bellaire,  Texas,  United States; Recruiting
      Local Institution, Desoto,  Texas,  United States; Not yet recruiting
      Local Institution, Houston,  Texas,  United States; Recruiting
      Local Institution, Houston,  Texas,  United States; Not yet recruiting
      Local Institution, San Antonio,  Texas,  United States; Recruiting
Virginia
      Local Institution, Herndon,  Virginia,  United States; Not yet recruiting
      Local Institution, Richmond,  Virginia,  United States; Not yet recruiting
Washington
      Local Institution, Bellevue,  Washington,  United States; Not yet recruiting
      Local Institution, Kirkland,  Washington,  United States; Recruiting
      Local Institution, Seattle,  Washington,  United States; Not yet recruiting
      Local Institution, Spokane,  Washington,  United States; Not yet recruiting
Wisconsin
      Local Institution, Milwaukee,  Wisconsin,  United States; Not yet recruiting

Study ID Numbers:  31-03-240
Record last reviewed:  May 2005
Last Updated:  May 10, 2005
Record first received:  May 9, 2005
ClinicalTrials.gov Identifier:  NCT00110461
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17