Effectivness of the Individualized QEEG-guided ML-driven Cranial electrotherapy stimulation(IEGMD-CES) in The treatment of Major Depressive Disorder
Phase 3
Recruiting
- Conditions
- Major depressive disorder.Major depressive disorder, single episode
- Registration Number
- IRCT20230112057118N1
- Lead Sponsor
- niversity of social welfare and rehabilitation sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Diagnosis of major depression based on the approval of a psychiatrist
Age 68-18
Not receiving anti-depressant and anti-anxiety medication in the last 4 weeks
Absence of psychosis and substance use disorder
Exclusion Criteria
Having a pacemaker
The presence of a metal object in the head and neck, except for implants and dental fillings
Pregnancy or breastfeeding
History of cerebrovascular disease, seizure, tumor or brain surgery and severe concussion
Severe cognitive disorders in the past year
Failure to complete at least 3 intervention sessions
The interval between two intervention sessions is more than two weeks
Occurrence of a psychiatric condition that requires other interventions, such as serious suicidal thoughts
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decreasing the depression score in the Beck's depression inventory. Timepoint: The beginning of the study, end and after one month. Method of measurement: Beck's depression inventory.
- Secondary Outcome Measures
Name Time Method Anxiety score. Timepoint: Before, after, and one month after intervention. Method of measurement: Beck's Anxiety inventory.;Sleep Quality. Timepoint: Before, after, and one month after intervention. Method of measurement: Pittsburgh Sleep Quality Index(PSQI).;Score of Memory. Timepoint: Before, after, and one month after intervention. Method of measurement: N-Back test.;Attention and consentration. Timepoint: Before, after, and one month after intervention. Method of measurement: Stroop test.