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

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02640911
• Other study ID #: SALT-C
• Status: Recruiting
• Start date: November 2010
• Est. completion date: May 2033

Study information

• Verified date: September 2021
• Source: Shanghai Mental Health Center
• Contact: Huafang Li, PH.D
• Phone: 86-21-34773128
• Email: lhlh_5[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: May 2033
• Est. primary completion date: May 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Systolic Blood Pressure	Measure blood pressure at 156 weeks	at 156 weeks
Primary	Change from Baseline liver function	Measure blood biochemical tests at 156 weeks	at 156 weeks
Primary	Change from Baseline PRL	Measure PRL level at 156 weeks	at 156 weeks
Primary	Change from Baseline thyroxine	thyroxine laboratory tests at 156 weeks	at 156 weeks
Primary	Number of Participants with EPS	EPS assessment at 156 weeks	at 156 weeks
Primary	Number of Participants with abnormal ECG	ECG examination at 156 weeks	at 156 weeks
Primary	Number of participants with abnormal sexual function	sexual function evaluation medication at 156 weeks	at 156 weeks
Secondary	Change from Baseline deduction of PANSS	PANSS assessment at 156 weeks	at 156 weeks
Secondary	Change from Baseline deduction of CGI-S	CGI-S assessment at 156 weeks	at 156 weeks
Secondary	Change from Baseline deduction of CDSS	CDSS assessment at 156 weeks	at 156 weeks
Secondary	Change from Baseline deduction of PSP	PSP assessment at 156 weeks	at 156 weeks