Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
NCT Number: NCT02640911
This multi-centre study will evaluate the safety and related factors study of atypical antipsychotics long-term treatment in Chinese Patients with Schizophrenia. The atypical antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine. This is an open, cohort, multi-center observational clinical study. The main purpose is to evaluate the safety. And the second purpose is to evaluate the efficacy of atypical antipsychotics. The efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. This study belongs to IV period post-marketing drugs research. Planned sample size is 3000 cases.
Visits occurs at 0,4,8,13,26,52,78,104,130 and 156 weeks. The main indexes include physical examination, vital signs, abdominal circumference , laboratory tests (blood cell analysis/ blood biochemical tests / prolactin (PRL) / thyroxine, etc.), adverse events, 12-lead electrocardiogram( ECG), extrapyramidal syndrome(EPS )assessment, sexual function evaluation, medication and other subjective feelings. The second indexes include scales of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-severity of Illness Scale(CGI-S), Calgary Depression Scale for Schizophrenia(CDSS),Personal and Social Performance Scale(PSP), the MOS 36一item Short Form Health Survey(SF-36), relapse rate, drug consolidation, medical-related expenses, income, drug plasma concentration and genetic information.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at 156 weeks
Measure blood pressure at 156 weeks
Time frame: at 156 weeks
Measure blood biochemical tests at 156 weeks
Time frame: at 156 weeks
Measure PRL level at 156 weeks
Time frame: at 156 weeks
thyroxine laboratory tests at 156 weeks
Time frame: at 156 weeks
EPS assessment at 156 weeks
Time frame: at 156 weeks
ECG examination at 156 weeks
Time frame: at 156 weeks
sexual function evaluation medication at 156 weeks
Time frame: at 156 weeks
PANSS assessment at 156 weeks
Time frame: at 156 weeks
CGI-S assessment at 156 weeks
Time frame: at 156 weeks
CDSS assessment at 156 weeks
Time frame: at 156 weeks
PSP assessment at 156 weeks
Contact information is provided by the study sponsor or research team.
Shanghai Mental Health Center
Other
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