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

NCT02640911 | Recruiting

• 1 other identifier: SALT-C
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Change from Baseline deduction of PANSS

  at 156 weeks

• Change from Baseline deduction of CGI-S

  at 156 weeks

• Change from Baseline deduction of CDSS

  at 156 weeks

• Change from Baseline deduction of PSP

  at 156 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese Patients with Schizophrenia

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (2)

• Weng J, Zhang L, Yu W, Zhao N, Zhu B, Ye C, Zhang Z, Ma C, Li Y, Yu Y, Li H. Risk factors, clinical correlates, and social functions of Chinese schizophrenia patients with drug-induced parkinsonism: A cross-sectional analysis of a multicenter, observational, real-world, prospective cohort study. Front Pharmacol. 2023 Mar 3;14:1077607. doi: 10.3389/fphar.2023.1077607. eCollection 2023.

  PMID: 36937864 DERIVED

• 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.

  PMID: 32695960 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Huafang Li, PH.D

CONTACT

86-21-34773128; lhlh_5@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: December 29, 2015
• Study Start: November 1, 2010
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2033
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

CN (1)