NCT05427578

Brief Summary

Functional near infrared spectroscopy (fNIRS) offers a cheap and reliable tool to investigate prefrontal brain activation in the healthy and diseased human brain. As such, fNIRS bears great potential as a diagnostic tool for clinical practice. Research indicates that fNIRS, together with a relatively simple task to activate the prefrontal cortex, the so-called verbal fluency task (VFT), elucidates prefrontal dysfunction in major depressive disorder (MDD). This finding can potentially serve as an imaging marker for disease pathology, even when depressive symptoms are absent. Indeed, recent research also suggests prefrontal dysfunction in fully remitted MDD (rMDD). Prefrontal haemodynamic responses may therefore serve as a trait marker for MDD vulnerability. This study aims to investigate the haemodynamic response in rMDD, healthy participants with increased MDD risk (HCr; having a 1st-degree relative with MDD), and low-risk healthy participants (HCnr; having no 1st-degree relatives with MDD) using fNIRS. The investigators hypothesize lower prefrontal reactivity in HCr compared to HCnr, and lowest prefrontal reactivity in rMDD compared to HCnr. This study has the potential to elucidate the neuronal underpinnings of depression vulnerability in the absence of symptoms that are sometimes considered a confounding factor when it comes to studying the biological encoding of depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2024

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2024

Enrollment Period

3.3 years

First QC Date

June 16, 2022

Last Update Submit

December 4, 2025

Conditions

Keywords

remitted major depressiondepression vulnerability

Outcome Measures

Primary Outcomes (1)

  • Oxygenated hemoglobin (HbO) change during VFT

    The HbO change during VFT measuring by fNIRS

    Up to 6 months

Secondary Outcomes (2)

  • Deoxygenated hemoglobin (HbR) change during VFT

    Up to 6 months

  • The VFT outcome

    Up to 6 months

Study Arms (3)

Remitted depression

Patients in full remission of a major depressive disorder (rMDD)

Other: fNIRS measurement

Healthy participants at risk

Healthy participants with increased MDD risk (having a 1st-degree relative with MDD)

Other: fNIRS measurement

Healthy participants low risk

Healthy participants with low MDD risk (having no 1st-degree relatives with MDD)

Other: fNIRS measurement

Interventions

measurement using functional near-infrared spectroscopy

Healthy participants at riskHealthy participants low riskRemitted depression

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

rMDD group: People who had major depressive disorders now fully remitted HCr group: Healthy control group with a high risk of depression, refer to as healthy volunteers who have a 1st-degree relative with MDD in this study. HCnr group: Healthy control group with a low risk of depression, refer to as healthy volunteers who have no a 1st-degree relative with MDD in this study.

You may qualify if:

  • Mini-mental state examination (MMSE) \> 24

You may not qualify if:

  • Current diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
  • current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Without collecting biospecimen.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Georg S Kranz, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 22, 2022

Study Start

August 1, 2021

Primary Completion

November 29, 2024

Study Completion

November 29, 2024

Last Updated

December 11, 2025

Record last verified: 2024-12

Locations