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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-28

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High real stimulation group

2mA tDCS stimulation daily (42 times) for 6 weeks

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation_High real

Intervention Type DEVICE

Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in high real stimulation group (2mA).

Low real stimulation group

1mA tDCS stimulation daily (42 times) for 6 weeks

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation_Low real

Intervention Type DEVICE

Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in Low real stimulation group (1mA).

Sham stimulation group

sham stimulation daily (42 times) for 6 weeks

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation_Sham

Intervention Type DEVICE

Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in sham stimulation group (0mA).

Interventions

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Transcranial direct current stimulation_High real

Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in high real stimulation group (2mA).

Intervention Type DEVICE

Transcranial direct current stimulation_Low real

Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in Low real stimulation group (1mA).

Intervention Type DEVICE

Transcranial direct current stimulation_Sham

Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in sham stimulation group (0mA).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No