TDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tdcs lDLPFC, tdcs rVLPFC, Sham.
- Who it may be relevant to
- Registry conditions: Subthreshold Depression, Young People, Transcranial Direct Current Stimulation. Basic parameters: 12 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcranial Direct Current Stimulation Interventions for Subthreshold Depressive Symptoms in Young Individuals.
Overview
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.
Interventions
- Device 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. - 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. - 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.
Primary outcome measures
- The effect of tDCS in alleviating subthreshold depressive symptoms [Time frame: 2 weeks, 1 month and 3 months]
Secondary outcome measures (2)
- Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms [Time frame: 2 weeks, 1 month and 3 months]
- To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms [Time frame: 2 weeks, 1 month and 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Guangzhou Brain hospital(Guangzhou Huiai Hospital) — Guangzhou
Identifiers
NCT: NCT06294184 · Guangzhou PH tDCS in SD