An observational study in Psychotic Disorders, sponsored by Genovate Biotechnology Co., Ltd.,. Status unknown. Open to participants aged 12 Years to 25 Years. Per ClinicalTrials.gov, last updated 2007-10-10.
Sponsored by Genovate Biotechnology Co., Ltd., · Observational
This is a 24-week, observational, prospective study to evaluate the effectiveness of improving cognitive function of aripiprazole in treating adolescents and young adults with psychotic disorder in Taiwan. Approximately 120 qualified patients who have clinical diagnosis of DSM-IV of psychotic symptom (e.g. schizophrenia or other psychotic disorders such as schizophreniform disorder, schizoaffective disorder, delusional disorder, shared psychotic disorder, bipolar disorder with psychotic feature or psychotic disorder not otherwise specified.) will be recruited to achieve at least 100 evaluable subjects. After signing the informed consent form, the demographics, medical history and concomitant medication will be recorded. Besides, physical examination, vital sign, BMI, DSM-IV multiaxial examination, CGI-S and menstrual history will be conducted. Laboratory tests and pregnancy test will be optionally conducted. After evaluating all variables obtained, the eligible patients will be enrolled into study. Patients who fulfill the inclusion / exclusion criteria will be performed the CPT, WCST, BPRS and WHOQOL. Afterwards, patients will be given their first medication at this visit (5 mg \~ 30 mg daily by subject). Besides, the switching period is maximum 8 weeks and is depended upon the clinical judgment of investigator. Efficacy will be evaluated by the change from baseline in Continuous Performance Test (CPT), Wisconsin Card Sorting Test (WCST), Clinical Global Impression Scale (CGI), Brief Psychiatric Rating Scale (BPRS) and The World Health Organization Quality of Life questionnaire (WHOQOL). Safety will be evaluated by the frequency of adverse events, abnormal laboratory results, physical examination, vital sign, BMI and menstrual history for female subgroup analysis.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
Browse Mental Disorders studies →Genovate Biotechnology Co., Ltd., is the lead sponsor of 12 studies on the registry; none are open to participants now.
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This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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Genovate Biotechnology Co., Ltd.,