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

Shanghai Mental Health Center3,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Schizophrenia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from Baseline Systolic Blood Pressure

Measure blood pressure at 156 weeks

Time frame: at 156 weeks

Change from Baseline liver function

Measure blood biochemical tests at 156 weeks

Time frame: at 156 weeks

Change from Baseline PRL

Measure PRL level at 156 weeks

Time frame: at 156 weeks

Change from Baseline thyroxine

thyroxine laboratory tests at 156 weeks

Time frame: at 156 weeks

Number of Participants with EPS

EPS assessment at 156 weeks

Time frame: at 156 weeks

Number of Participants with abnormal ECG

ECG examination at 156 weeks

Time frame: at 156 weeks

Number of participants with abnormal sexual function

sexual function evaluation medication at 156 weeks

Time frame: at 156 weeks

Secondary Outcomes

Change from Baseline deduction of PANSS

PANSS assessment at 156 weeks

Time frame: at 156 weeks

Change from Baseline deduction of CGI-S

CGI-S assessment at 156 weeks

Time frame: at 156 weeks

Change from Baseline deduction of CDSS

CDSS assessment at 156 weeks

Time frame: at 156 weeks

Change from Baseline deduction of PSP

PSP assessment at 156 weeks

Time frame: at 156 weeks

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts