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

Recruiting

• Conditions: Schizophrenia

• Registration Number: NCT02640911
• Lead Sponsor: Shanghai Mental Health Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14
• Primary Completion: 2030-05
• Study Completion: 2033-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with abnormal ECG	at 156 weeks	ECG examination at 156 weeks
Change from Baseline liver function	at 156 weeks	Measure blood biochemical tests at 156 weeks
Change from Baseline thyroxine	at 156 weeks	thyroxine laboratory tests at 156 weeks
Change from Baseline Systolic Blood Pressure	at 156 weeks	Measure blood pressure at 156 weeks
Change from Baseline PRL	at 156 weeks	Measure PRL level at 156 weeks
Number of Participants with EPS	at 156 weeks	EPS assessment at 156 weeks
Number of participants with abnormal sexual function	at 156 weeks	sexual function evaluation medication at 156 weeks

Secondary Outcome Measures

Name	Time	Method
Change from Baseline deduction of CGI-S	at 156 weeks	CGI-S assessment at 156 weeks
Change from Baseline deduction of PANSS	at 156 weeks	PANSS assessment at 156 weeks
Change from Baseline deduction of PSP	at 156 weeks	PSP assessment at 156 weeks
Change from Baseline deduction of CDSS	at 156 weeks	CDSS assessment at 156 weeks

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China