Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otsuka Pharmaceutical Co., Ltd.
Age
13–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-IV-TR
Male and female patients aged 13-17 years
Patients completing the 031-09-003 study
Patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study
Inpatient or outpatient status
You may not be if
Patients who have a diagnosis of any other disease except schizophrenia, according to DSM-IV-TR
Patients who have been compulsorily admitted to hospital
Patients with mental retardation
Patients with thyroid disorder
Patients who fall under a contraindication listed in the ABILIFY package insert
Patients with a serious hepatic, renal, cardiac or hematopoietic disorder
Patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy
Patients with a history or a complication of diabetes and patients who fall under any of the following: fasting blood glucose level ≧ 126 mg/dL, non-fasting blood glucose level ≧ 200 mg/dL, HbA1c ≧ 6.5%
Patients with a history or a complication of suicide attempt, suicidal thought or self-harm
Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS
Patients with a history or a complication of malignant syndrome, tardive dyskinesia or paralytic ileus
Patients in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
Patients with a history or a complication of water intoxication
Patients with Parkinson's disease
Pregnant women, parturient women, nursing women, women of childbearing potential who wish to become pregnant during this trial. However, women of childbearing potential who are practicing an appropriate method of contraception (refer to 8.6) and have a negative pregnancy test result are eligible for inclusion in this study.
Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator
