Non-medicine InterventionNCT04513275
Research on Accurate Prediction of Long-term Medication Use for Schizophrenia Based on Cognitive Function
An observational study of Non-medicine Intervention, run by Shanghai Mental Health Center.
Trial summary
Chinese version of the cognitive function test of schizophrenia (MCCB) . To explore a predictive model for long-term medication use in patients based on cognitive function Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-medicine Intervention
- What is being tested?
- non-medicine intervention
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years
Who may be able to join
- Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years _Meet the diagnostic criteria for schizophrenia in ICD-10
Who cannot join
- Other people with mental illness
About this study
Chinese version of the cognitive function test of schizophrenia (MCCB) . To explore a predictive model for long-term medication use in patients based on cognitive function
- Conditions
- Non-medicine Intervention
- Being tested
- non-medicine intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-medicine interventionDrug
Also called rating by MATRICS Consensus Cognitive Battery,MCCB
rating by MCCB only one time
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia patient group | Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years Receives: Drug: non-medicine intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of MATRICS Consensus Cognitive Battery
Measured: 1 day (only one time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-medicine InterventionStudies 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
- Cross-sectional
- Enrolment
- 500 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
- NCT04513275
- Sponsor's protocol ID
- PLFSBC
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Accurate Prediction of Long-term Medication Use for Schizophrenia Based on Cognitive Function
- ClinicalTrials.gov ID
- NCT04513275
- Acronym / sponsor ID
- PLFSBC
- Conditions
- Non-medicine Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 14 Aug 2020 (actual)
- 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.
Chinese version of the cognitive function test of schizophrenia (MCCB) . To explore a predictive model for long-term medication use in patients based on cognitive function
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| schizophrenia patient group | – | Drug: non-medicine interventionSchizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years
Key inclusion criteria (1 listed)
- Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years _Meet the diagnostic criteria for schizophrenia in ICD-10
Key exclusion criteria (1 listed)
- Other people with mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-medicine interventionAlso: rating by MATRICS Consensus Cognitive Battery,MCCBrating by MCCB only one time | Drug | schizophrenia patient group |
Primary outcome
Score of MATRICS Consensus Cognitive Battery
Time frame: 1 day (only one time)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Non-medicine Intervention
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
Coronary Artery Disease (CAD)
Recruiting
IMB-Guided Health Education Intervention for Medication Adherence and Blood Pressure Control in Non-adherent Hypertensive Patients
Hypertension
Active, not recruitingObservational study
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Primary Biliary Cholangitis
Active, not recruitingObservational study
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-medicine Intervention, run by Shanghai Mental Health Center.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of MATRICS Consensus Cognitive Battery (time frame: 1 day (only one time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2020.