Actively Recruiting

Age: 18Years +
All Genders
NCT02640911

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China, 200030

Actively Recruiting

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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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