Research on Accurate Prediction of Long-term Medication U... | NCT04513275

Studies
Research on Accurate Prediction of Long-term Medication Use for Schizophrenia Based on Cognitive Function

NCT04513275

Sponsor

Shanghai Mental Health Center

Status

Unknown status

Last Update Posted

Aug 14, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Non-medicine Intervention

Interventions

non-medicine intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Estimated

Primary Completion Date

Sep 30, 2022Estimated

Completion Date

Sep 30, 2022Estimated

First Submitted Date

Aug 12, 2020

First Submission Date that Met QC Criteria

Aug 13, 2020

First Posted Date

Aug 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2020

Last Update Posted Date

Aug 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
schizophrenia patient group		Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years	Drug: non-medicine intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-medicine intervention	Drug	rating by MCCB only one time	schizophrenia patient group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score of MATRICS Consensus Cognitive Battery		1 day (only one time)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years _Meet the diagnostic criteria for schizophrenia in ICD-10

Exclusion Criteria:

Other people with mental illness

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Schizophrenia patients with first episode and disease duration of 5, 10, 20, and 30 years

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided