A Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 631.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to determine the safety of aripiprazole administered
      long-term in doses ranging from 10 to 30 mg per day as a maintenance therapy in subjects with
      chronic or first episode of schizophrenia. Information on the continued efficacy of
      aripiprazole was also gathered in this long-term trial (until 31 Dec 2012 or until
      aripiprazole was otherwise available through marketed means and/or reimbursed).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Complete a Prior Study: each patient must meet one of the following conditions for
             completion of the prior study:

               -  A patient who has completed 52 weeks of post-randomization treatment in the prior
                  double blind study (31-97-301 or 31-98-304-01) is eligible, with no further
                  qualifications.

               -  A patient who was early-terminated from the study 31-97-301 or 31-98- 304-01 for
                  either of the following two reasons is eligible to enter this open label study
                  with no minimal required duration of prior double-blind participation:

                    -  Early termination was due to a marked deterioration of clinical status and
                       no serious adverse events (SAE) other than hospitalization has occurred. The
                       marked clinical deterioration must be documented by at least a one-point
                       increase in CGI-Severity score from the baseline and a score of 6 (much
                       worse) or 7 (very much worse) in CGI-Global Improvement at the time of
                       termination, or

                    -  Early termination was due to a non-serious AE requiring discontinuation of
                       the study drug

               -  A patient who was early terminated after a minimum of 4 weeks' participation in
                  the double-blind treatment in study 31-97-301 or 31-98- 304-01 and the reason for
                  early termination was withdrawal of consent due to lack of effect but not marked
                  deterioration. This must be documented by no change from baseline in the
                  CGI-Severity score and a score of 4 (no change) or 5 (minimally worse) on the
                  CGI-Global Improvement scale.

          2. Signing of Informed Consent Form: Prior to any procedure or drug administration, each
             patient must sign an informed consent form. In addition, if required by the Ethical
             Committee, each patient's next-of-kin or responsible caregiver will co-sign the
             patient's consent form or a separate consent form.

        Exclusion Criteria:

          1. Patients suffering from any significant somatic disease or medical problem that would
             obscure the results of treatment, or that might require frequent changes of
             concomitant medication.

          2. Patients with any acute or unstable medical condition requiring pharmacotherapy, other
             than schizophrenia.

          3. Patients with an abnormal laboratory test value in the most recent analysis (from the
             study 31-97-301 or 31-98-304-01) which is considered by the investigator as presenting
             a significant risk to the patient for continuing treatment with aripiprazole.

          4. Patients who were early-terminated from the prior double-blind studies (31-97-301 or
             31-98-304-01) due to a serious adverse event (SAE) other than worsening of psychosis
             or hospitalization.

          5. Female patients of child bearing potential with a positive serum pregnancy test at the
             baseline (last visit of prior study) of this open-label follow-on study.

          6. Patients who have positive result in the urine screen for drugs of abuse (except for
             cannabis or medically-prescribed analgesics or benzodiazepines.)