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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Device: Transcranial direct current stimulation_High real; Device: Transcranial direct current stimulation_Low real; Device: Transcranial direct current stimulation_Sham

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.

• Study Type: Interventional
• Enrollment (Anticipated): 141
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ji-Hyun Baek; Phone Number: +82 2-2008-4388; Email: jh1.baek@samsung.com

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Recruiting
    • Seoul National University Bundang Hospital
    • Contact: Woojae Myung, MD, PhD; Phone Number: +31)31-787-2720; Email: smbhealer@gmail.com
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Ji-Hyun Baek, M.D., Ph.D.; Phone Number: +82 1093355988; Email: jihyunbaek@skku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High real stimulation group; 2mA tDCS stimulation daily (42 times) for 6 weeks	Device: Transcranial direct current stimulation_High real; Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in high real stimulation group (2mA).
Active Comparator: Low real stimulation group; 1mA tDCS stimulation daily (42 times) for 6 weeks	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).
Sham Comparator: Sham stimulation group; sham stimulation daily (42 times) for 6 weeks	Device: Transcranial direct current stimulation_Sham; Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in sham stimulation group (0mA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working memory ability evaluation(N-Back tast)	N-back tasks are continuous-recognition measures that present stimulus sequences, such as letters or pictures; for each item in the sequence, people judge whether it matches the one presented n items ago. As the number of correct answers increases, it means improvement in cognitive function.	Change from Baseline Working memory ability evaluation at 6 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Rating Scale	The patient is rated by a clinician on 17 items scored either on a 3-point or 5-point Likert-type scale. The lower the total score, the better the symptoms.	Change from Baseline Hamilton Rating Scale evaluation at 2,4,6 weeks
Hamilton Anxiety Rating Scale	The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Upon the completion of the evaluation, the clinician compiles a total, composite score based upon the summation of each of the 14 individually rated items. This calculation will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity.The lower the total score, the better the symptoms.	Change from Baseline Hamilton Anxiety Rating Scale evaluation at 2,4,6 weeks

Collaborators and Investigators

• Sponsor: ji hyun baek, MD, Ph.D
• Investigators: Principal Investigator: Ji-Hyun Baek, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: YB_ST_IIT2006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No