MedPath

Study on the Efficacy and Safety of Transcranial Alternating Current Stimulation in Patients with Depressive Episodes

Phase 1
Conditions
depression
Registration Number
ChiCTR2400088960
Lead Sponsor
The Affiliated Brain Hospital of Guangzhou Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Age between 13 and 85 years, regardless of gender;<br>Meeting the diagnostic criteria for major depressive episode as outlined in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), including major depressive disorder, bipolar I disorder, and bipolar II disorder;<br>Scoring =17 on the 17-item Hamilton Depression Rating Scale (HAMD-17);<br>Having a stable medication regimen for the past 4 weeks prior to enrollment;<br>Not having received transcranial magnetic stimulation, transcranial electrical stimulation, or electroconvulsive therapy within the last 6 months;<br>Having sufficient auditory and visual abilities to complete the necessary assessments required for the study;<br>Agreeing to participate in the study and signing the informed consent form.

Exclusion Criteria

Meeting any other diagnostic criteria outlined in DSM-5;<br>High suicide risk: currently having suicidal thoughts or plans, scoring 3 or 4 on the suicide item of the HAMD-17 scale, or being judged by the researcher to have a high suicide risk;<br>Hypothyroidism or major physical illnesses such as heart, liver, or kidney diseases that render the individual unable to tolerate the study;<br>Neurological diseases such as central nervous system infections, stroke, hydrocephalus, brain tumors, or epilepsy;<br>History of epileptiform discharges confirmed by electroencephalography (EEG);<br>Current use of anticonvulsant medications;<br>Currently undergoing psychotherapy;<br>Having contraindications for MRI examination, such as having a pacemaker implanted or an arterial clip retained after craniocerebral surgery;<br>Having ferromagnetic materials inside the body, such as retained metal foreign bodies, artificial metal valves after heart surgery;<br>Having metal prostheses, metal joint replacements, insulin pumps, or neurostimulators.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
17-HAMD;EEG;
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath