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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04709952
• Other study ID #: YB_ST_IIT2006
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2021
• Source: Samsung Medical Center
• Contact: Ji-Hyun Baek
• Phone: +82 2-2008-4388
• Email: jh1.baek[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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).
• Transcranial direct current stimulation_Low real
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in Low real stimulation group (1mA).
• Transcranial direct current stimulation_Sham
Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in sham stimulation group (0mA).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
ji hyun baek, MD, Ph.D

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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