Program for the Introduction Into Clinical Practice of th... | NCT05090644

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2022Actual

Primary Completion Date

Jan 20, 2023Actual

Completion Date

Jan 20, 2023Actual

First Submitted Date

Sep 25, 2021

First Submission Date that Met QC Criteria

Oct 21, 2021

First Posted Date

Oct 25, 2021Actual

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

Mar 13, 2023

Last Update Posted Date

Mar 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ildar Fakhradiyev, Head of the Laboratory of Experimental Medicine, Asfendiyarov Kazakh National Medical UniversityPrincipal Investigator

Lead Sponsor

Asfendiyarov Kazakh National Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

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

This is a GWAS study that aims to identify possible candidate genes associate to schizophrenia by exploring single nucleotide polymorphism (SNP) in a group of schizophrenia, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associated with schizophrenia

Detailed Description

A genome-wide association study (GWAS) is an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies.

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

Retention

Enrollment

700Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group:		Patients with schizophrenia	Genetic: DNA analysis
Control group		Patients without schizophrenia	Genetic: DNA analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNA analysis	Genetic	GWAS	Control group Experimental group:

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of SNPs associated with schizophrenia	Using GWAS to identify candidate genes associate with schizophrenia	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

persons of Kazakh nationality having this ethnicity in the 3rd generation
age from 18 to 65 years old;
the dispensary in a psychiatric institution at the place of residence with a diagnosis of "Paranoid schizophrenia";
the duration of the disease is at least 1 year (from the moment of taking under dispensary supervision):
absence of severe and chronic somatic diseases;
absence of severe and chronic neurological diseases;
absence of comorbid drug addiction pathology;
signed informed consent to conduct this study

Exclusion Criteria:

persons of non-Kazakh nationality and Kazakh nationality, not confirmed until the 3rd generation
age less than 18 years old and over 65 years old;
those who are on dispensary registration in a psychiatric institution at the place of residence with a diagnosis not related to ICD-10 under the heading F20.0 "Paranoid schizophrenia";
having a disease duration of less than 1 year (from the moment of taking under dispensary supervision):
having severe and chronic somatic diseases;
having severe and chronic neurological diseases;
having comorbid narcological pathology;
not signed informed consent to conduct this study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Kazakh population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kuanysh Altynbekov, PhD	Republican Scientific and Practical Center for Mental Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Republican Scientific and Practical Center for Mental Health		Almaty		050000	Kazakhstan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders