SchizophreniaNCT02640911
An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia
An observational study of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to May 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese Patients with Schizophrenia
Who may be able to join
- 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
Who cannot join
- Participation in other clinical studies.
- Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Huafang Li, PH.D, 86-2134773128, lhlh_5@163.com
About this study
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
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Systolic Blood Pressure
Measure blood pressure at 156 weeks
Measured: at 156 weeks
Change from Baseline liver function
Measure blood biochemical tests at 156 weeks
Measured: at 156 weeks
Change from Baseline PRL
Measure PRL level at 156 weeks
Measured: at 156 weeks
Change from Baseline thyroxine
thyroxine laboratory tests at 156 weeks
Measured: at 156 weeks
Number of Participants with EPS
EPS assessment at 156 weeks
Measured: at 156 weeks
Number of Participants with abnormal ECG
ECG examination at 156 weeks
Measured: at 156 weeks
Number of participants with abnormal sexual function
sexual function evaluation medication at 156 weeks
Measured: at 156 weeks
Secondary outcomes (4)
Change from Baseline deduction of PANSS
PANSS assessment at 156 weeks
Measured: at 156 weeks
Change from Baseline deduction of CGI-S
CGI-S assessment at 156 weeks
Measured: at 156 weeks
Change from Baseline deduction of CDSS
CDSS assessment at 156 weeks
Measured: at 156 weeks
Change from Baseline deduction of PSP
PSP assessment at 156 weeks
Measured: at 156 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startNov 2010
- Primary completionMay 2030 (estimated)
- Study completionMay 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640911
- Sponsor's protocol ID
- SALT-C
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2015
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36937864He 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.
PubMed 32695960
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02640911
- Acronym / sponsor ID
- SALT-C
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2033 (estimated)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese Patients with Schizophrenia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in other clinical studies.
- Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline Systolic Blood Pressure
Time frame: at 156 weeks
Measure blood pressure at 156 weeks
Change from Baseline liver function
Time frame: at 156 weeks
Measure blood biochemical tests at 156 weeks
Change from Baseline PRL
Time frame: at 156 weeks
Measure PRL level at 156 weeks
Change from Baseline thyroxine
Time frame: at 156 weeks
thyroxine laboratory tests at 156 weeks
Number of Participants with EPS
Time frame: at 156 weeks
EPS assessment at 156 weeks
Number of Participants with abnormal ECG
Time frame: at 156 weeks
ECG examination at 156 weeks
Number of participants with abnormal sexual function
Time frame: at 156 weeks
sexual function evaluation medication at 156 weeks
4 secondary outcomes
Change from Baseline deduction of PANSS
Time frame: at 156 weeks
Change from Baseline deduction of CGI-S
Time frame: at 156 weeks
Change from Baseline deduction of CDSS
Time frame: at 156 weeks
Change from Baseline deduction of PSP
Time frame: at 156 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 36937864Weng 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.
- Derived from this study: PubMed 32695960He 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huafang Li, PH.D (86-21-34773128, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Systolic Blood Pressure (time frame: at 156 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02640911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.