ClinicalTrials.gg
RecruitingNCT06294184Updated Dec 12, 2024

TDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.

An interventional study of tdcs lDLPFC and tdcs rVLPFC in Subthreshold Depression, Young People and Transcranial Direct Current Stimulation, sponsored by Guangzhou Psychiatric Hospital. Recruiting at 1 site in China. Open to participants aged 12 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Guangzhou Psychiatric Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Nov 2023, registered Feb 2024).
  • Started Nov 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
12 Years to 25 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 357 studies in Depression with a site in China — 118 open to participants now, 137 under way, 3 of them phase 3. Depression · China.

Planned enrollment
130th of 283
150 · median 132
Started
2023
with 43 others
No phase
217 of 357
70 open now
Primary completion
2025-12
later than 43 of 136 live
Registered
209th of 357
by date
Lead sponsor
7 of 357
Guangzhou Psychiatric Hospital

Among the 357 studies in Depression with a site in China, this one is the 130th largest by planned enrollment of the 283 interventional ones, is one of 44 that started in 2023, is one of 217 with no phase, reaches primary completion later than 43 of the 136 other live ones, and was the 209th registered.

By phase

357 studies; the count open now beside each. This study's row is marked.

No phasethis study217 · 70 open
Observational74 · 30 open
Phase 424 · 10 open
Phase 115 · 2 open
Phase 211 · 2 open
Phase 37 · 2 open
Phase 2/36 · 1 open
Phase 1/23 · 1 open

By the year they started

First in 2006; this study’s year is marked. 44 started in 2023.

Size and results

Median enrollment 132 across the 283 interventional studies, 306 across the 74 observational. Of the 140 that completed or were terminated, 9 (6%) have results posted.

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02

Study summary

The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out.

Read the detailed description

After being informed about the study and potential risks, all participants providing written informed consent will undergo screening to determine eligibility for study entry. On day 0, participants who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1:1 ratio to receive tDCS targeting the left dorsolateral prefrontal cortex (lDLPFC), tDCS targeting the right ventrolateral prefrontal cortex (rVLPFC), or Sham stimulation (10 sessions in 2 weeks). At baseline, after 2 weeks of stimulation, and at follow-up after 1 month and 3 months, participants will be assessed for brain network function, depressive symptoms, emotional status and social interactions.

03

Conditions studied

  • Subthreshold Depression
  • Young People
  • Transcranial Direct Current Stimulation

Browse trials for

Keywords

  • Resting-state brain functional network
  • Social emotion
04

Who can participate

Ages eligible
12 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Be between the ages of 12-25;
    1. is right-handed on the Edinburgh Handedness Inventory;
    1. 2-4 of the 9 depressive symptoms defined by the American Diagnostic and Statistical Manual of Diseases, Fifth Edition (), lasting more than 1 week; or more than 5 depressive symptoms lasting more than 1 week but less than 2 weeks (i.e., not meeting criteria for a major depressive episode) (by DSM-5 Clinical Semi-Definitive Interview (K-SADS-PL) (Gilbody et al., 2017, JAMA);
    1. Hamilton Depression Scale (HAMD-24) 24 points≥ 8 points, \< 24 points;
    1. Gender is not limited;
    1. Subjects and their families voluntarily participate and sign the form.

Exclusion criteria

Exclusion Criteria:

    1. Individuals with the following diagnoses according to : psychiatric disorders due to organic diseases, substance-related and addictive disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder (assessed by K-SADS-PL);
    1. Have two or more DSM-V-defined manic symptoms for 4 days but do not meet the criteria for hypomania or meet the DSM-V defined criteria for hypomanic symptoms for only 2-3 days;
    1. Severe or unstable physical illness;
    1. have a moderate or higher risk of suicide (as assessed by the Columbia Suicide Severity Scale);
    1. Received transcranial direct current stimulation in the past three months (continuous intervention time: >2 weeks);
    1. to transcranial direct current stimulation, such as brain implants, personal or family history of epilepsy;
    1. Magnetic resonance scanning is contraindicated, such as in vivo metal implants.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    lDLPFC tdcs stimulation group

    The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3, cathode is on the FP2.

    Device: tdcs lDLPFC

  • Experimental
    rVLPFC tdcs stimulation group

    The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F6, cathode is on the FP1.

    Device: tdcs rVLPFC

  • Sham comparator
    Sham group

    The current only persist in the fisrt 30s, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3/F6, cathode is on the FP2/1.

    Device: Sham

Interventions

  • Devicetdcs lDLPFC

    The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3, cathode is on the FP2.

  • Devicetdcs rVLPFC

    The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F6, cathode is on the FP1.

  • DeviceSham

    The current only persist in the fisrt 30s, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3/F6, cathode is on the FP2/1.

06

What researchers measure

Primary outcomes

  1. The effect of tDCS in alleviating subthreshold depressive symptoms

    In young individuals with subthreshold depressive symptoms, we used a latent growth model to test whether 10 trials of tDCS for stimulation of lDLPFC or rVLPFC had immediate and sustained (1 \&amp; 3 months follow-up) effects on altered depressive symptoms, LPFC-DMN function regulation, positive and negative emotional processing. The latent growth curve model can fit the data well at multiple time points and analyze the correlation of the rate of change of multiple variables. We will measure participants' emotions using the original word score that has been pre-experimentally confirmed, and use the Dynamic Causal Modelling to calculate the resting-state functional regulation of LPFC to DMN (rsFC intensity from LPFC to DMN). We randomized young individuals 1:1:1 to lDLPFC, rVLPFC, and pseudo-stimulation (sham) to test the tDCS effect.

    Time frame: 2 weeks, 1 month and 3 months

Secondary outcomes

  1. Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms

    We will examine the cross-sectional association between LPFC-DMN functional regulation, positive and negative emotional processing, and depressive symptoms at each time point, and test whether there is a longitudinal association between the immediate and persistent effects of tDCS on the above variables. We will use the cross-lagged structure equation model to test whether the effects of tDCS on LPFC-DMN functional regulation (neural mechanism) and positive and negative emotional processing (affective mechanism) significantly mediate the effect of tDCS on depressive symptoms (outcome variables). We will clarify the temporal sequence of mechanism-outcome effects by testing whether mechanism effects at earlier time points can prospectively predict outcome effects at subsequent time points to infer causal relationships.

    Time frame: 2 weeks, 1 month and 3 months

  2. To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms

    Based on the above analysis results, we will use the Connectome-Based Predictive Model (CPM) method to construct emotional neural data models that predict individual effects. With the advantage of data fitting in machine learning methods, we will screen emotional neurovariables that are significantly related to the level and change of depressive symptoms based on the results of the above mechanism, and build a prediction model around them. We will focus on testing a machine learning model that prospectively predicts the effect of individual interventions: this model will use baseline or earlier time point data to predict the tDCS effect longitudinally at subsequent time points of individual participants. We will also integrate all variables that are cross-sectionally and vertically associated with the level and change of solitary autonomy to build a comprehensive predictive model.

    Time frame: 2 weeks, 1 month and 3 months

07

Study locations

1 of 1 sites recruiting
  • Guangzhou Brain hospital(Guangzhou Huiai Hospital)
    Guangzhou, Guangdong 510370, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Dec 2025, 25 months after the start.

Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 25 months is above that.

Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2024
First posted
Mar 5, 2024
StartActual
Nov 1, 2023
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Dec 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06294184
Lead sponsor
Guangzhou Psychiatric Hospital
Responsible party
Kangguang Lin (Professor, Guangzhou Psychiatric Hospital) — Principal investigator
First posted
Mar 5, 2024
Start date
Nov 1, 2023
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Dec 12, 2024

Study contacts

Kangguang Lin, M.D;Ph.D
Contact
linkangguang@163.com
86-02081268189
Kangguang Lin, M.D;PH.D
study director · The Affiliated Brain Hospital of Guangzhou Medical University
Robin Shao, Ph.D
principal investigator · The Affiliated Brain Hospital of Guangzhou Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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