Depression
Conditions
Interventions
?-tACS Group:Transcranial alternating current stimulation (tACS) at theta frequency (4-8 Hz), targeting frontoparietal region (active electrode at F3, return electrodes at Fp1, Fz, C3, and F7), 30 min
?-tACS Group:Transcranial alternating current stimulation (tACS) at gamma frequency (30-70 Hz), targeting frontoparietal region (active electrode at F3, return electrodes at Fp1, Fz, C3, and F7), 30 m
Sham Group:Sham stimulation with 10 Hz frequency for 1 minute, then abruptly terminated without participant awareness, 30 minutes per session, 5 times per week for 30 sessions
Sponsors
Shanghai mental health center
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Meets DSM-5 criteria for major depressive episode in remission for at least one month; 2. HAMD-17 score <= 7 at enrollment; 3. Self-reported subjective cognitive dysfunction (e.g., difficulty concentrating, slowed thinking, difficulties learning or remembering) and Digit Symbol Substitution Test (DSST) score < 70; 4. Aged 18–60 years; 5. Right-handed, with normal hearing and vision (or corrected to normal); 6. Education level of middle school or above, ensuring the ability to understand and complete necessary study assessments; 7. Stable medication regimen (including antidepressants, mood stabilizers, atypical antipsychotics, etc.) for at least 2 weeks prior to enrollment and maintained throughout the 20 treatment sessions (4 weeks); 8. Written informed consent obtained from the participant (or legal guardian).
Exclusion criteria
Exclusion criteria: 1. Exclusion of other Axis I mental disorders besides depression via the MINI-International Neuropsychiatric Interview (MINI); 2. Acute or chronic renal failure; cirrhosis or active liver disease; 3. Abnormal laboratory findings deemed clinically significant by the investigator, potentially affecting study efficacy or subject safety; 4. Severe or unstable physical illnesses, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, increased intracranial pressure, cranial surgery, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), sleep apnea syndrome, malignancy, immunocompromised subjects, and subjects with blood glucose levels exceeding 12 mmol/L; 5. Individuals with heavy alcohol consumption within 30 days prior to trial initiation or history of alcohol or drug dependence within 6 months prior to trial; 6. Pregnant or lactating women. Male or female subjects not using effective contraception, or planning to conceive or become pregnant within 3 months after trial initiation; 7. Family history of epilepsy (within two generations on either side); 8. Skin/cranial conditions: Abnormal electrode placement sites, such as open wounds; 9. Recent use of benzodiazepines, antiepileptic drugs, or mood stabilizers (calculated based on 5 drug half-lives); 10. Received any neuromodulation therapy within the past three months, including electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or any form of transcranial electrical stimulation (tES); 11. Presence of tACS contraindications: intracranial metallic foreign bodies, pacemakers, cochlear implants, or intracranial hypertension; 12. Participation in any clinical trial within 30 days prior to baseline; 13. Other conditions deemed by the investigator to make the subject unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Digit Symbol Substitution Test (DSST) Score from Baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction Rate of Hamilton Depression Rating Scale-17 (HAMD-17) Total Score;Change in Theta-Gamma Coupling (TGC) in Frontoparietal Region;Theta Power in Frontoparietal Region;Gamma Power in Frontoparietal Region;Cognitive Symptom Assessment (THINC-it, PDQ-D, MGH-CPFQ, BC-CCI);Depressive Symptoms;Anxiety Symptoms;Psychotic Symptoms;Working Memory Tasks (Visual-Spatial Working Memory, Sternberg, Flanker, WCST, AVLT, Stroop);Quality of Life; | — |
Countries
China
Contacts
Public ContactChen Yiming
Shanghai mental health center
Outcome results
None listed