Bipolar disorder is characterized by dramatic mood swings ranging from both high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania co-exist (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes associated with bipolar disorder. This is a 12-week study that will test the safety and efficacy of this medication. In addition to open-label lithium or valproic acid, all subjects will receive either asenapine or placebo (no active medication). Subjects will be required to stay in the hospital for at least seven days during treatment. Those completing the study may be eligible to continue in an extension study for an additional 40 weeks (information was omitted due to their commercial sensitivity, and will be revealed at a later date).

Condition	Intervention	Phase
Bipolar Disorder	Drug: Asenapine	Phase III

Further Study Details: 

Primary Outcomes: Improvement in bipolar manic symptoms (information was omitted due to their commercial sensitivity, and will be revealed at a later date).
Secondary Outcomes: (Information was omitted due to their commercial sensitivity, and will be revealed at a later date)
Expected Total Enrollment:  320

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

Criteria

Inclusion Criteria:

• Have bipolar I disorder, current episode manic or mixed
• Treated with lithium or valproic acid

Exclusion Criteria:

• Have an unstable medical condition
• Clinically significant laboratory abnormality.
• Have a primary diagnosis other than bipolar I disorder.

Please refer to this study by ClinicalTrials.gov identifier  NCT00145470

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

Arkansas
      Pfizer Investigational Site, Jonesboro,  Arkansas,  72401,  United States; Recruiting
      Pfizer Investigational Site, Little Rock,  Arkansas,  72211,  United States; Recruiting
California
      Pfizer Investigational Site, Oceanside,  California,  92056,  United States; Recruiting
Florida
      Pfizer Investigational Site, Miami,  Florida,  33125,  United States; Recruiting
      Pfizer Investigational Site, Miami,  Florida,  33180,  United States; Recruiting
      Pfizer Investigational Site, Ft. Lauderdale,  Florida,  33308,  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, North Miami,  Florida,  33161,  United States; Recruiting
      Pfizer Investigational Site, Sunrise,  Florida,  33325,  United States; Recruiting
      Pfizer Investigational Site, Ft. Lauderdale,  Florida,  33301,  United States; Recruiting
      Pfizer Investigational Site, North Miami,  Florida,  33161,  United States; Recruiting
Louisiana
      Pfizer Investigational Site, New Orleans,  Louisiana,  70114,  United States; Recruiting
      Pfizer Investigational Site, New Orleans,  Louisiana,  70117,  United States; Recruiting
Maryland
      Pfizer Investigational Site, Baltimore,  Maryland,  21285-6815,  United States; Recruiting
Tennessee
      Pfizer Investigational Site, Madison,  Tennessee,  37115,  United States; Recruiting
Texas
      Pfizer Investigational Site, Dallas,  Texas,  75234,  United States; Recruiting
      Pfizer Investigational Site, De Soto,  Texas,  75115-2242,  United States; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A7501008
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145470
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06