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NCT Number: NCT02640911

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

Huafang Li, PH.D

CONTACT

[email protected]

86-2134773128

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • An in-patient or out-patient (male or female) and aged ≥18 years
  • A diagnosis of schizophrenia,DSM-IV(Diagnostic and Statistical Manual Diploma in Social Medicine-IV)
  • 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.
  • Patients are taking or will take atypical antipsychotics which include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine

Exclusion criteria

  • Participation in other clinical studies.
  • Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.

Treatment and study plan

Primary outcomes

  1. Change from Baseline Systolic Blood Pressure

    Time frame: at 156 weeks

    Measure blood pressure at 156 weeks

  2. Change from Baseline liver function

    Time frame: at 156 weeks

    Measure blood biochemical tests at 156 weeks

  3. Change from Baseline PRL

    Time frame: at 156 weeks

    Measure PRL level at 156 weeks

  4. Change from Baseline thyroxine

    Time frame: at 156 weeks

    thyroxine laboratory tests at 156 weeks

  5. Number of Participants with EPS

    Time frame: at 156 weeks

    EPS assessment at 156 weeks

  6. Number of Participants with abnormal ECG

    Time frame: at 156 weeks

    ECG examination at 156 weeks

  7. Number of participants with abnormal sexual function

    Time frame: at 156 weeks

    sexual function evaluation medication at 156 weeks

Secondary outcomes

  1. Change from Baseline deduction of PANSS

    Time frame: at 156 weeks

    PANSS assessment at 156 weeks

  2. Change from Baseline deduction of CGI-S

    Time frame: at 156 weeks

    CGI-S assessment at 156 weeks

  3. Change from Baseline deduction of CDSS

    Time frame: at 156 weeks

    CDSS assessment at 156 weeks

  4. Change from Baseline deduction of PSP

    Time frame: at 156 weeks

    PSP assessment at 156 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Huafang Li, PH.D

CONTACT

[email protected]

86-21-34773128

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2030
Study completion
2033
First posted
Dec 29, 2015
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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