EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUT... | NCT06369805

Studies
EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION

NCT06369805

Sponsor

Les Toises - Psychiatry and Psychotherapy Center

Status

Completed

Last Update Posted

Apr 17, 2024Actual

Enrollment

307Actual

Phase

Not provided

Conditions

Depressive Disorder
Bipolar Disorder
Bipolar Depression

Interventions

there is no intervention

Countries

Switzerland

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

Apr 2024

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

Jun 2, 2021Actual

Primary Completion Date

Nov 17, 2022Actual

Completion Date

Nov 17, 2022Actual

First Submitted Date

Apr 12, 2024

First Submission Date that Met QC Criteria

Apr 12, 2024

First Posted Date

Apr 17, 2024Actual

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

Apr 12, 2024

Last Update Posted Date

Apr 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment.

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

307Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
one group			Other: there is no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
there is no intervention	Other	there is no intervention	one group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psychiatric symptomatology	self- and hetero-psychiatric scales	Once

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult outpatients suffering from depression and/or bipolar disorders who gave their written informed consent to participate in the present study

Exclusion Criteria:

Any patient without capacity of discernment or with harmful use of psychoactive substances

Accepts Healthy Volunteers

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

Adult outpatients suffering from depression and/or bipolar disorders

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Les Toises - Psychiatry and Psychotherapy Center		Lausanne		1005	Switzerland

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

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided