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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Huafang Li, PH.D; Phone Number: 86-21-34773128; Email: lhlh_5@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: Huafang Li, PH.D; Phone Number: 86-2134773128; Email: lhlh_5@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chinese Patients with Schizophrenia

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline deduction of PANSS	PANSS assessment at 156 weeks	at 156 weeks
Change from Baseline deduction of CGI-S	CGI-S assessment at 156 weeks	at 156 weeks
Change from Baseline deduction of CDSS	CDSS assessment at 156 weeks	at 156 weeks
Change from Baseline deduction of PSP	PSP assessment at 156 weeks	at 156 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Publications and helpful links

General Publications

• He S, Yu WJ, Wang X, Zhang L, Zhao N, Li G, Shen YF, Li H. Risk factors of hyperprolactinemia induced by risperidone and olanzapine and their correlations with plasma glucose and lipids. Gen Psychiatr. 2020 Jul 6;33(4):e100206. doi: 10.1136/gpsych-2020-100206. eCollection 2020.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ANTICIPATED): May 1, 2030
• Study Completion (ANTICIPATED): May 1, 2033

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (ESTIMATE): December 29, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: SALT-C