Effectivness of the Individualized QEEG-guided ML-driven Cranial electrotherapy stimulation(IEGMD-CES) in The treatment of Major Depressive Disorder

The comparison of the Individualized QEEG-guided ML-driven Cranial electrotherapy stimulation(IEGMD-CES) with conventional Cranial electrotherapy stimulation in The treatment of Major Depressive Disorder: Double-blind, randomized clinical trial of efficacy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230112057118N1

Enrollment

Registered

2023-09-16

Start date

2023-09-23

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Major depressive disorder. Major depressive disorder, single episode

Interventions

Intervention 1: Intervention group: the group with major depression who start IEGMD-CES treatment. Intervention 2: Intervention group: the group with major depression who start C-CES treatment.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahimeh Saeed

University of social welfare and rehabilitation sciences

Fa.saeed@uswr.ac.ir+98 21 2218 0140

Outcome results

None listed

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