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The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder

Y

Ybrain

Status

Completed

Conditions

Depression

Treatments

Device: Mind STIM

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04720040
YB_ST_SIT1902

Details and patient eligibility

About

This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.

Full description

Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5~7 times a week and they were evaluated every 2weeks through questionnaires.

Enrollment

65 patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features)
  • Patients with a K-BDI-II score of 14 or more and 28 or less
  • In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life.

Exclusion criteria

  • Patients diagnosed with Axis I disorders other than major depressive disorder
  • Patients diagnosed with other depressive disorders besides major depressive disorder
  • Patients who have attempted suicide within 6 months of screening
  • Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems
  • Patients judged to have other reasons for prohibition of use of tDCS medical devices
  • Patients currently taking antidepressants

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

65 participants in 1 patient group

YMS-201B
Experimental group
Description:
transcranial Direct Current Stimulation (tDCS) application 5 \~7 days a week for 6 weeks (total of 30\~42 applications)
Treatment:
Device: Mind STIM

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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