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Clinical Trials/NCT06294184
NCT06294184
Recruiting
Not Applicable

Transcranial Direct Current Stimulation Interventions for Subthreshold Depressive Symptoms in Young Individuals.

Guangzhou Psychiatric Hospital1 site in 1 country150 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subthreshold Depression
Sponsor
Guangzhou Psychiatric Hospital
Enrollment
150
Locations
1
Primary Endpoint
The effect of tDCS in alleviating subthreshold depressive symptoms
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guangzhou Psychiatric Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kangguang Lin

Professor

Guangzhou Psychiatric Hospital

Eligibility Criteria

Inclusion Criteria

  • Be between the ages of 12-25;
  • is right-handed on the Edinburgh Handedness Inventory;
  • 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);
  • Hamilton Depression Scale (HAMD-24) 24 points≥ 8 points, \< 24 points;
  • Gender is not limited;
  • Subjects and their families voluntarily participate and sign the informed consent form.

Exclusion Criteria

  • 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);
  • 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;
  • Severe or unstable physical illness;
  • have a moderate or higher risk of suicide (as assessed by the Columbia Suicide Severity Scale);
  • Received transcranial direct current stimulation in the past three months (continuous intervention time: \>2 weeks);
  • Contraindications to transcranial direct current stimulation, such as brain implants, personal or family history of epilepsy;
  • Magnetic resonance scanning is contraindicated, such as in vivo metal implants.

Outcomes

Primary Outcomes

The effect of tDCS in alleviating subthreshold depressive symptoms

Time Frame: 2 weeks, 1 month and 3 months

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 \& 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.

Secondary Outcomes

  • Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms(2 weeks, 1 month and 3 months)
  • To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms(2 weeks, 1 month and 3 months)

Study Sites (1)

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