perimenopausal depression
Conditions
Interventions
GAD experimental group:A 10-day regimen with real stimulus administered twice daily, each session lasting 40 minutes. The parameters for tACS were set at 15 mA and 77.5 Hz.
GAD control group:A 10-day regimen with sham stimulus administered twice daily, each session lasting 40 minutes. The sham stimulus delivered no electrical current output.
Perimenopausal Depression experimental group:A 10-day regimen with real stimulus administered twice daily, each session lasting 40 minutes. The parameters for tACS were set at 15 mA and 77.5 Hz.
Perimenopausal Depression control group:A 10-day regimen with sham stimulus administered twice daily, each session lasting 40 minutes. The sham stimulus delivered no electrical current output.
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Generalized Anxiety Disorder: 1. Diagnosis of Generalized Anxiety Disorder (GAD) by two psychiatrists according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed via the Structured Clinical Interview for DSM-5 (SCID-5), and currently experiencing an anxiety episode defined as HAMA score >=14. 2. Ages must be between 18 and 60 years old (inclusive), regardless of gender. 3. Right-handed. 4. Completed at least junior high school education and capable of providing informed consent and completing cognitive tests. 5. Medication-naïve participants received no pharmacologic treatment during the treatment period, whereas participants receiving stable medication for at least 8 weeks before enrollment continued their existing regimens without dose or drug changes throughout the treatment period. Inclusion Criteria for Depressive Disorder: 1. Patients must have been diagnosed with major depressive disorder by two psychiatrists, and meet DSM-5 criteria for major depressive disorder as determined by the SCID interview. Patients must be currently experiencing a depressive episode (HAMD >= 17). 2. Female, aged 45 to 60 years old, meeting the World Health Organization (WHO) Research Group on Menopause's definition of perimenopause (experiencing irregular menstruation or natural amenorrhea). 3. Must be right-handed. 4. Must have a junior high school education or higher, and possess the ability to complete the informed consent process and cognitive tests. 5. For first-time patients who have not taken any medication, no medication will be used during the 10-day treatment period; or for patients who have been under stable medication treatment for more than 8 weeks without significant changes, the treatment plan will remain unchanged during the 10-day treatment period.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Generalized Anxiety Disorder: 1. History of psychiatric disorders other than 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. Exclusion Criteria for Depressive Disorder: 1. A history of psychiatric illness other than MDD or generalized anxiety disorder; 2. Pregnant or breastfeeding women; 3. History of head trauma or coma; 4. Organic brain or severe physical illness (e.g., thyroid disease, lupus erythematosus, diabetes, infection, major trauma, etc.); 5. Physical therapy (e.g., ECT, rTMS, etc.) within the past six months; 6. Suspected or confirmed history of alcohol or drug dependence; 7. Current severe suicidal ideation or suicide attempts; 8. Currently taking psychoactive medications or participating in other clinical trials; 9. Positive urine drug screen or abnormal thyroid function test results; 10. Any contraindications to MRI or EEG examinations; 11. Inability to provide fully informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in HAMD-17 and/or HAMA scores between the experimental and control groups at day 10; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate;Remission rate;Changes in HAMD-17 subscales, HAMA subscales, VAS, PHQ, GAD, and PDQ scores at the end of 5 days, 10 days, and 2 months of treatment;Changes in CGI, ASI, STAI, BSSI, and SHAPS scores at the end of 5 and 10 days of treatment;Changes in cognitive function test scores at the end of 5 and 10 days of treatment;Changes in SDS, PSS, CD-RISC, and RRS scores at the end of 10 days of treatment; | — |
Countries
China
Contacts
Public ContactZexuan Li
The Second Xiangya Hospital of Central South University
Outcome results
None listed