Clinical trial NCT02640911: An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese Patients with Schizophrenia

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Systolic Blood Pressure
timeFrame: at 156 weeks
measure: Change from Baseline liver function
timeFrame: at 156 weeks
measure: Change from Baseline PRL
timeFrame: at 156 weeks
measure: Change from Baseline thyroxine
timeFrame: at 156 weeks
measure: Number of Participants with EPS
timeFrame: at 156 weeks
measure: Number of Participants with abnormal ECG
timeFrame: at 156 weeks
measure: Number of participants with abnormal sexual function
timeFrame: at 156 weeks
Secondary outcomes:
measure: Change from Baseline deduction of PANSS
timeFrame: at 156 weeks
measure: Change from Baseline deduction of CGI-S
timeFrame: at 156 weeks
measure: Change from Baseline deduction of CDSS
timeFrame: at 156 weeks
measure: Change from Baseline deduction of PSP
timeFrame: at 156 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
citation: 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.