Postmarketing Clinical Trial of tDCS to Evaluate Cognitive Ability in Depression Patients

ClinicalTrials.gov ID

NCT04709952

Lead Sponsor

ji hyun baek, MD, Ph.DOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

141Estimated

Last Update Posted

Sep 23, 2021Actual

Start Date

Jan 28, 2021Actual

Primary Completion Date

Mar 31, 2023Estimated

Completion Date

Jun 30, 2023Estimated

Official Title

A Clinical Trial Study on the Market to Establish the Safety and Efficacy of a Transcranial DC Stimulation Device in Patients With Depression

Brief Summary

This study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1mA), high real stimulation group (2mA) and treatment every day for 6 weeks (a total of 42 times). As a primary outcome, the investigator analyze the improvement effect of working memory ability, and confirm whether the effects of anxiety and depression are improved by the secondary outcome, together with the quality of life evaluation.

Detailed Description

During the clinical trial period, a total of 4 to 5 outpatient visits are made, and changes are evaluated through neuropsychological examination by visiting at 2, 4 and 6 weeks based on the baseline time point. In addition, in the case of patients who agree after 6 weeks of participation, an additional 6 weeks of high real stimulation is used to conduct an open extension study.

• Depression

• Transcranial direct current stimulation_High real
• Transcranial direct current stimulation_Low real
• Transcranial direct current stimulation_Sham

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Diagnosis of major depressive disorder
2. CGI severity (severity of Illness) score of 3 or higher
3. Patients receiving medication for depression at the time of study participation
4. Those who can read and understand the subject's explanation and consent form and who can respond to questionnaires

Exclusion Criteria:

1. History of clinically significant medical neurological disease or history of head injury
2. In case of mental retardation or cognitive impairment enough to affect the writing of consent form or conducting research
3. Severe suicidal risk or psychotic symptoms determined by the clinician
4. In the case of a contraindication to the implementation of tDCS (when a metallic auxiliary tool is inserted in the head)
5. Those who are judged to have problems with the attachment of EEG and DC stimulation electrodes due to deformities, inflammatory reactions, or other dermatological problems at the electrode attachment site
6. Among female subjects who are likely to become pregnant, those who do not agree to contraception by a medically acceptable method for up to 24 weeks after application of the investigational medical device in this clinical trial
7. Pregnant women
8. Any other person who has reasons to judge that the investigator is unsuitable for participation in the clinical trial

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

ji hyun baek, MD, Ph.DOTHER

jihyunbaek@skku.edu+82 1093355988

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