Study of Aripiprazole in Patients With Schizophrenia- Effects on Glucose Metabolism-
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole
Intervention description: 1 or 2 times a day, p.o., 6 - 24mg a day
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: OPC-14597; Schizophrenia

Summary:

      The objective of this study is to examine the effects of aripiprazole on glucose metabolism
      in schizophrenic patients without hyperglycemia and diabetes mellitus or any history thereof.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female patients who are 16 years or older when written informed consent was
             obtained.

          2. Patients who give personal written informed consent to participate in this study.

          3. Patients who meet any of the following criteria for antipsychotic-naive or currently
             antipsychotic-free patients or patients who have been treated with antipsychotics
             indicated for schizophrenia from the onset of schizophrenia until the time of giving
             informed consent.

             Antipsychotic-naive or currently antipsychotic-free patients

               -  Patients who do not take any antipsychotics

               -  Patients who have taken antipsychotics for less than 2 years and discontinued
                  them for 12 weeks prior to giving informed consent

             Patients recently treated with antipsychotics

               -  Patients who have taken antipsychotics for more than 2 years and are taking
                  antipsychotics at the time of giving informed consent

          4. Patients who meet all of the following conditions

               -  Patients who do not have any obvious complication of diabetes mellitus

               -  Patients who do not have any obvious medial history with antidiabetic agents

               -  Patients with no obvious history of diabetes mellitus recorded in the current
                  charts of the study site at the time of giving informed consent

               -  Patients who have not shown any values for the following parameters that deviate
                  from the standard laboratory values in the current charts of the study site at
                  the time of giving informed consent

               -  Patients whose laboratory values meet all of the following criteria in the
                  clinical laboratory tests conducted after patients give informed consent, just
                  before commencement of study drug administration.

                    -  Fasting blood glucose level (FBS) <110mg/dL (If FBS is not available,
                       non-fasting blood glucose level*1 <140mg/dL)

                       *1 : For cases in which blood sugar measurements include values that cannot
                       be judged as having been obtained in the fasted state.

                    -  HbA1c <5.8% Fasting blood glucose is defined as glucose concentrations in
                       plasma samples taken between 5 a.m. and 12 noon after at least eight hours
                       of fasting (including abstinence from snacks and calorie-containing juice,
                       coffee, etc. ). All other blood glucose measurements of are counted random
                       glucose.

          5. Patients who have no obvious family history (in parents or siblings) of diabetes
             mellitus at the time of commencement of study drug administration

          6. Patients whose body mass index (BMI) is less than 25 kg/m2 in the current charts of
             the study site at the time of giving informed consent Body Mass Index (BMI) = Body
             weight in kg /(height in m)2

        Exclusion Criteria:

          1. Patients who have been given aripiprazole after market launching

          2. Patients who clearly experienced symptoms of polydipsia, including so-called
             PET-bottle syndrome (hyperglycemia caused when the supply of insulin, which promotes
             glucose metabolism, becomes insufficient due to continuous soft drink consumption) and
             water intoxication, within one year prior to giving informed consent

          3. Patients taking drugs that affect glucose metabolism

          4. Patients who take quetiapine fumarate (Seroquel) or olanzapine (Zyprexia) within a
             period from 12 weeks prior to commencement of study drug administration to immediately
             before commencement of study drug administration

          5. Patients with the following complications Abnormal adrenal function, abnormal
             pituitary function, abnormal thyroid function, chronic pancreatitis, chronic
             hepatitis, alcoholic hepatopathy, non-alcoholic fatty liver, and liver cirrhosis

          6. Female patients who are known to have given birth to a macrosomatic infant exceeding
             4000 g in weight

          7. Patients given antipsychotics at doses equivalent to 20 mg/day or more of haloperidol
             (or, in the case of multi-drug therapy, a combined equivalence of 20 mg/day or more of
             haloperidol) within a period from 12 weeks prior to commencement of study drug
             administration to immediately before commencement of study drug administration

          8. Patients in a major state of excitation or stupor immediately before commencement of
             study drug administration

          9. Patients who are forcibly hospitalized

         10. Patients given any investigational new drugs within 12 weeks prior to commencement of
             study drug administration

         11. Patients diagnosed as having a complication of serious hepatic, renal, cardiac, or
             haematopoietic disorder within 4 weeks prior to commencement of study drug
             administration, according to the criteria specified below.

             Hepatic disorder: Total bilirubin ≥ 3.0 mg/dL, AST (GOT) and ALT (GPT) ≥2.5 times the
             upper limits of normal levels at the study site.

             Renal disorder: Creatinine ≥ 2 mg/dL Heart: Congestive heart failure arrhythmias, and
             ischemic heart disease being treated by drug therapy Haematopoietic disorder, etc.:
             RBC < 3,000,000, Hb <10.0 g/dL, WBC < 3,000, platelet counts < 7,500

         12. Pregnant or lactating women, women shown to be possibly pregnant by the pregnancy
             examination conducted immediately before commencement of study drug administration,
             and women who are hoping to become pregnant within one year after providing informed
             consent to participate in the study

         13. Patients who meet any of the criteria for contraindication listed on the package
             insert of aripiprazole

         14. Patients with a complication or history of neuroleptic malignant syndrome or a related
             condition

         15. Patients suffering physical exhaustion associated with dehydration or malnutrition,
             etc.

         16. Patients with a complication or history of paralytic ileus

         17. Patients with a history of alcohol dependence or drug abuse

         18. Patients with a history of suicide attempt, or patients who have a high possibility of
             committing self-injury or attempting suicide

         19. Patients with a complication or history of convulsion disorders, such as epilepsy, or
             structural brain disorders

         20. Patients considered in the judgment of the principal investigator or the attending
             investigator to be inappropriate for inclusion in the study for any other reason