A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
Condition: Bipolar I Disorder
MeSH terms: Bipolar Disorder
Intervention: Aripiprazole
Intervention description: oral, 24mg(4 tablets)/day
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To assess the safety and efficacy of long-term administration of aripiprazole by performing
      extended administration of aripiprazole in combination with mood stabilizer (lithium or
      valproate) in an unblinded manner to those patients who completed the preceding multicenter,
      double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients
      with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter
      "Study 003") but whose condition worsened or remained unchanged or who discontinued Study 003
      between Day 14 and Day 21 due to lack of drug efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Trial subjects will be men and women of age 18 or above and below the age of 65 who
             will not be turning 65 during the trial.

          -  Subjects have the ability to understand and to provide informed consent to the
             examination, observation, and evaluation processes specified in this protocol, and
             have signed the informed consent form based on a full understanding of the trial.

          -  Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been
             diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was
             manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed"

          -  Subjects who were enrolled in and have completed or withdrawn from Study 003 and who
             meet the following criteria

               -  Subjects who show exacerbation of condition or no change in condition: Those
                  subjects who completed Study 003, and whose score for CGI-BP Change from
                  preceding phase (mania) on Day 21 (completion of Study 003) was between 5
                  (Minimally worse) and 7 (Very much worse) (subjects showing exacerbation of
                  condition), or whose score was 4 (No change) (subjects showing no change in
                  condition)

               -  Subjects who discontinued due to lack of drug efficacy: Those subjects who
                  discontinued Study 003 between Day 14 and Day 21, for whom the reason of
                  withdrawal was lack of drug efficacy, and whose score for CGI-BP Change from
                  preceding phase (mania) was between 5 (Minimally worse) and 7 (Very much worse)

        Exclusion Criteria:

          -  Subjects presenting with a clinical picture and/or history that is consistent with a
             DSM-IV-TR diagnosis of:

               -  Delirium, dementia, amnestic disorder, or other cognitive disorders

               -  Schizophrenia or other psychotic disorder

               -  Personality disorder

          -  Subjects with psychotic symptoms that are clearly due to another general medical
             condition or direct physiological effects of a substance

          -  Subjects who represent a significant risk of committing suicide

          -  Subjects known to have a complication of allergy to aripiprazole, other
             quinolinone-skeleton compounds, lithium, or valproate

          -  Subjects with a complication of neuroleptic malignant syndrome

          -  Subjects in a state of physical exhaustion accompanied by such conditions as
             dehydration or malnutrition

          -  Subjects with a complication of paralytic ileus

          -  Subjects with a complication of organic brain disorder or convulsive disorder, such as
             epilepsy

          -  Subjects with a complication of diabetes