TDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.

NCT ID: NCT06294184

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Subthreshold Depression Young People Transcranial Direct Current Stimulation

Keywords

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Resting-state brain functional network Social emotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

tdcs lDLPFC

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

tdcs rVLPFC

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

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.

Interventions

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tdcs lDLPFC

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

Intervention Type DEVICE

tdcs rVLPFC

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

Intervention Type DEVICE

Sham

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\) Be between the ages of 12-25;
* 2\) is right-handed on the Edinburgh Handedness Inventory;
* 3\) 2-4 of the 9 depressive symptoms defined by the American Diagnostic and Statistical Manual of Diseases, Fifth Edition (DSM-5), 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);
* 4\) Hamilton Depression Scale (HAMD-24) 24 points≄ 8 points, \< 24 points;
* 5\) Gender is not limited;
* 6\) Subjects and their families voluntarily participate and sign the informed consent form.

Exclusion Criteria

* 1\) Individuals with the following diagnoses according to DSM-5: 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);
* 2\) 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;
* 3\) Severe or unstable physical illness;
* 4\) have a moderate or higher risk of suicide (as assessed by the Columbia Suicide Severity Scale);
* 5\) Received transcranial direct current stimulation in the past three months (continuous intervention time: \>2 weeks);
* 6\) Contraindications to transcranial direct current stimulation, such as brain implants, personal or family history of epilepsy;
* 7\) Magnetic resonance scanning is contraindicated, such as in vivo metal implants.
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou Psychiatric Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kangguang Lin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kangguang Lin, M.D;PH.D

Role: STUDY_DIRECTOR

The Affiliated Brain Hospital of Guangzhou Medical University

Robin Shao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Brain Hospital of Guangzhou Medical University

Locations

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Guangzhou Brain hospital(Guangzhou Huiai Hospital)

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kangguang Lin, M.D;Ph.D

Role: CONTACT

Phone: 86-02081268189

Email: [email protected]

Facility Contacts

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Kangguang Lin, M.D;Ph.D

Role: primary

Other Identifiers

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Guangzhou PH tDCS in SD

Identifier Type: -

Identifier Source: org_study_id