Schizophrenia
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Shanghai Mental Health Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. An in-patient or out-patient (male or female) and aged ≥18 years 2. A diagnosis of schizophrenia,DSM-IV(Diagnostic and Statistical Manual Diploma in Social Medicine-IV) 3. Subjects must have the ability to effectively communicate with investigator,complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study specific assessments or procedures. 4. Patients are taking or will take atypical antipsychotics which include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine
Exclusion criteria
1. Participation in other clinical studies. 2. Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal sexual function | at 156 weeks | sexual function evaluation medication at 156 weeks |
| Change from Baseline PRL | at 156 weeks | Measure PRL level at 156 weeks |
| Change from Baseline thyroxine | at 156 weeks | thyroxine laboratory tests at 156 weeks |
| Number of Participants with EPS | at 156 weeks | EPS assessment at 156 weeks |
| Number of Participants with abnormal ECG | at 156 weeks | ECG examination at 156 weeks |
| Change from Baseline Systolic Blood Pressure | at 156 weeks | Measure blood pressure at 156 weeks |
| Change from Baseline liver function | at 156 weeks | Measure blood biochemical tests at 156 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline deduction of CGI-S | at 156 weeks | CGI-S assessment at 156 weeks |
| Change from Baseline deduction of CDSS | at 156 weeks | CDSS assessment at 156 weeks |
| Change from Baseline deduction of PSP | at 156 weeks | PSP assessment at 156 weeks |
| Change from Baseline deduction of PANSS | at 156 weeks | PANSS assessment at 156 weeks |
Countries
China
Contacts
Primary ContactHuafang Li, PH.D
Outcome results
None listed