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An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia

Recruitingn/aAges 18 Years - anyAllShanghai Mental Health Center
NCT02640911 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 bioche

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Shanghai Mental Health Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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