A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
Condition: Bipolar I Disorder
MeSH terms: Bipolar Disorder
Intervention: Aripiprazole; placebo
Intervention description: oral, 24mg(4 tablets)/day; oral, 0mg(4tablets)/day
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To investigate the safety and efficacy of long-term administration of aripiprazole by
      performing extended administration of the treatment administered in 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") in a double-blind manner to those patients who complete
      Study 003 and demonstrate 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 Study 003 and who meet the following
             criteria for demonstration of drug efficacy

          -  Subjects demonstrating drug efficacy:

               -  Those subjects who completed Study 003 whose score for CGI-BP Change From
                  Preceding Phase (mania) at the time of evaluation on Day 21 of Study 003
                  (completion) was between 1 (Very much improved) and 3 (Minimally improved)

        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 or other
             quinolinone-skeleton compounds

          -  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