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Efficacy and Safety of Personalized Transcranial Alternating Current Stimulation with different treatment frequencies for Major Depressive Disorder

Efficacy and Safety of Personalized Transcranial Alternating Current Stimulation with different treatment frequencies for Major Depressive Disorder: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082267
Enrollment
Unknown
Registered
2024-03-26
Start date
2024-04-09
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major depressive disorder

Interventions

low-frequency fixed stimulation group:10Hz transcranial alternating current stimulation once daily
high-frequency fixed stimulation group:10Hz transcranial alternating current stimulation twice daily
low-frequency individualized stimulation group:individual alpha frquency transcranial alternating current stimulation once daily
high-frequency individualized stimulation group:individual alpha frequency transcranial alternating current stimulation twice daily

Sponsors

Beijing Anding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1: Meeting DSM-V diagnostic criteria for major depressive disorder without psychotic symptoms 2: Age 18-55 3: No treatment with MECT/ECT, TMS, tDCS 1 month prior to enrollment 4: No psychiatric medication use 14 days prior to enrollment 5: 17-item Hamilton Depression Rating Scale (HAMD-17) score =17 at enrollment and HAMD-17 entry 1 (depressed mood) score =2 6: Have understood all aspects of the study and signed the informed consent form

Exclusion criteria

Exclusion criteria: 1: Meets DSM-V Other Psychiatric Diagnoses 2: Serious or unstable organic disease 3: Pregnant and breastfeeding women, patients unable to use suitable contraception during the trial period 4: History of seizures, epilepsy, hydrocephalus or CNS tumors, acute brain injury and infection 5: Impaired skin integrity at the electrode placement site, allergy to electrode gels or adhesives 6: With implantable electronic stimulator 7: Previous manic or hypomanic episodes 8: with a HAMD-17 3 (suicide) score of =3 9: Patients with prior suicidal behavior or existing strong suicidal ideation 10: Participants in any other clinical trial within 1 month prior to baseline 11: The researcher believes that there are circumstances that make participation in this study inappropriate 12: Researchers directly participating in this study or their immediate family members

Design outcomes

Primary

MeasureTime frame
effectiveness at the end of treatment;

Secondary

MeasureTime frame
Early effectiveness at 1 week;HAMD-17 factor scores;Effectiveness at 4 week;Changes in QIDS-SR16;Changes in GAD-7;Changes in HAMA;electroencephalography;Perceived Deficit Questionnaire for Depression 5-item,PDQ-5D;Sheehan Disability Scale, SDS;Ask Suicide-Screening Questions, ASQ;

Countries

China

Contacts

Public ContactJingjing Zhou

Beijing Anding Hospital

fishjj_0907@163.com+86 10 5834 0320

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026