Actively Recruiting
An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia
Led by Shanghai Mental Health Center · Updated on 2021-09-14
3000
Participants Needed
1
Research Sites
1173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Diagnosis of schizophrenia according to DSM-IV criteria
- Ability to communicate effectively, understand the consent form, and provide written informed consent
- Currently taking or planning to take atypical antipsychotics such as quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone, amisulpride, perospirone, or clozapine
You will not qualify if you...
- Participation in other clinical studies
- Any condition judged by the investigator to make the patient unsuitable for this clinical study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
H
Huafang Li, PH.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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