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Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder and Generalized Anxiety Disorder

NCT07712159

Not Yet RecruitingNA

Sponsor: Central South University

Conditions: Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD)

Interventions: Temporal Interference transcranial Alternating Current Stimulation (TI-tACS), Sham Temporal Interference transcranial Alternating Current Stimulation (TI-tACS)

This multi-center, double-blind study, randomized controlled trial aims to evaluate the efficacy and safety of Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in patients with major depressive disorder (MDD) and generalized anxiety disorder (GAD). All participants will be enrolled as two independent cohorts and randomized separately within each diagnostic group. Participants with major depressive disorder will be randomized to receive high-frequency TI-tACS(130 Hz), low-frequency TI-tACS(2Hz), or sham stimulation targeting the right amygdala. Participants with generalized anxiety disorder will be randomized to receive high-frequency TI-tACS(80Hz), low-frequency TI-tACS(5Hz), or sham stimulation targeting the right amygdala. The intervention consists of 20 stimulation sessions administered over 2 weeks (twice a day for 5 consecutive days, followed by a 2-day break, and another 5 consecutive days). Clinical assessments will be conducted at baseline, during treatment, and at multiple follow-up time points up to 6 months. The primary outcome for the MDD cohort is the change from baseline in the Hamilton Depression Rating Scale (HAMD-17) at week 2. The primary outcome for the GAD cohort is the change from baseline in the Hamilton Anxiety Rating Scale (HAMA) at week 2. Secondary outcomes include changes in clinical symptoms, cognitive function, and safety profiles in both the MDD and GAD cohorts.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 55 years (inclusive), any gender;
2. Diagnosis of a single or recurrent episode of Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) according to DSM-5 criteria, assessed by trained researchers using the Structured Clinical Interview for DSM-5 (SCID), without psychotic features;
3. For MDD participants: HAMD-17 score ≥14; inadequate response to stable, regular antidepressant medication for at least 1 month at an adequate dose;
4. For GAD participants: HAMA score ≥14; stable, regular medication for at least 2 months;
5. Education level: junior high school or above; adequate cognitive and language ability to understand and complete study assessments;
6. Voluntary participation with signed informed consent; ability to comply with study visits, treatment schedules, laboratory tests, and other study procedures.

Exclusion Criteria:

1. History of psychiatric disorders other than MDD or GAD;
2. Pregnancy or lactation;
3. Neurologic disorders or serious systemic diseases (e.g., thyroid disease, lupus erythematosus, diabetes, hepatic or renal impairment, active infection, major trauma);
4. History of significant head injury or coma
5. Receipt of physical therapies such as electroconvulsive therapy or rTMS within the past six months before enrollment
6. Suspected or confirmed history of alcohol or substance dependence;
7. Current severe suicidal ideation or recent suicide attempt;
8. Current participation in another clinical trial or recent use of prohibited psychotropic medications;
9. Positive urine drug screening or abnormal thyroid function tests;
10. Contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG);
11. Inability to provide fully informed consent.