tDCS(Transcranial Direct Current Stimulation) Efficacy in Bipolar Depression : RCT Study

Augmentative Transcranial Direct Current Stimulation (tDCS) in Patients With Bipolar Depression: RCT, IIT Study.

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective and safe in the treatment Bipolar depression.

Randomized, double-blind Controlled Clinical Trial. Subjects Adults (between 19 and 65 years of age) with Bipolar depression who meet the inclusion criteria and who agree to participate in the study Will recruit from clinical referrals.

• Active tDCS Anode - left DLPFC Cathode - right DLPFC Electric current is 2mA - Current is applied for 30 min
• Sham tDCS Same assembly is used Current is applied for 1 min

Both groups 30~42 stimulation sessions on consecutive days.

Baseline(visit 1), 2 week(visit 2), 4 week(visit 3), 6 week(visit 4), and 12 week(visit 5) Check compliance with mobile application(MINDD-CONNECT) connections.

Study Overview

• Status: Unknown
• Conditions: tDCS
• Intervention / Treatment: Device: ACTIVE; Device: SHAM

Detailed Description

Assessment:

Depression rating scale: HAM-D(Hamiltion Depresiion Rating Scale), HAM-A(Hamilton Anxiety Rating Scale) Maniac rating scale: YMRS(Young Mania rating scale) CGI-BP(Clinical Global Impression-Bipolar) Q-LES-Q-SF(Quality of Life Enjoyment and Satisfaction Short form) Q-LES-Q-Q(Quality of Life Enjoyment and Satisfaction Questionnaire) qEEG(Quantitative Electroencephalography)

Check compliance with mobile application(MINDD-CONNECT) connections.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Boondang, Gyunggi
    • Seongnam-si, Boondang, Gyunggi, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Boondang Hospital
      • Contact: Woojae Myung, MD, PhD; Phone Number: +82)31-787-2720; Email: smbhealer@gmail.com

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:

• Type I or Type II of bipolar disorder meets the current major depression diagnostic criteria in DSM-5
• CGI Severity of lightness score ≥ 4 points
• Taking mood stabilizers for at least four weeks before the day of screening

Exclusion Criteria:

• A history of clinically significant internal neurological disorders or head injury
• mental retardation or cognitive impairment that will affect to make a consent form.
• Patients at risk of suicide that may require hospitalization as determined by clinicians
• A person who is determined to be excluded for using tDCS medical device for other reason (e.g. metal plate is inserted on head, etc.)
• A person who is determined to have problems with scalp deformation, inflammatory response or brain wave and attachment of direct current because of other dermatological problem

• A woman who disagree with medically allowed contraception* until 24 weeks after the application of investigational device among woman subject who is possible to get pregnant

  * Medically allowed contraception: condom, oral contraception for at least 3 month, injection or insert contraception, Intrauterine Device, etc.

• pregnant woman or lactating woman
• A person who is not suitable for this clinical trial based on principal investigator's determination other than above reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ACTIVE; Active stimulation (tDCS) will be used in the dose of 2mA /30 min per day, for 6weeks. (minimum 5 times per week)(total of 30~42 sessions)	Device: ACTIVE; We will use 28.26cm^2 round electrodes and a 2mA current for 30 minutes per day. This montage is known as "bifrontal" setup(F3-Anode, F4-Cathode) and has been previously used in major depression trials.
SHAM_COMPARATOR: SHAM; Sham stimulation (tDCS) will be used in the dose of 0mA /30 min per day, for 6weeks. (minimum 5 times per week)(total of 30~42 sessions)	Device: SHAM; We will use 28.26cm^2 round electrodes and a 0mA current for 30 minutes per day. This montage is known as "bifrontal" setup(F3-Anode, F4-Cathode) and has been previously used in major depression trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes in HAM-D	The changes in HAM-D(Hamilton Depression scale) will constitute the major research outcome measure. HAM-D17; clinician-administered scale; assesses 17 items related to major depression (MD); Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe.; Total score: 0 to 66.	baseline, 2week, 4week, 6week
Response rate of treatment	Response group: Reduce of HAM-D 50%	baseline, 6week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAM-A	Hamilton Anxiety Rating Scale; Rating clinician-related; Main purpose to assess the severity of symptoms of anxiety; Population adults, adolescents and children; The scale consists of 14 items; Each item is scored on a scale of 0-4, with a total score range of 0-56; <17: mild severity, 18-24: mild to moderate severity, 25-30: moderate to severe	baseline, 2week, 4week, 6week
YMRS	Young Mania Rating Scale; Rating clinician-related or other trained rater; Main purpose to assess the severity of symptoms of manic; Population young adults and children; The scale consists of 11 items; Each item is scored on a scale of 0-8 or 0-4, with a total score range of 0-60; The higher score, the worse it means.	baseline, 2week, 4week, 6week
CGI-BP	Clinical Global Impression- Bipolar	baseline, 2week, 4week, 6week
Q-LES-Q-SF	Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form	baseline, 2week, 4week, 6week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
qEEG	The changes of qEEG analysis	baseline, 2week

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ybrain Inc.

Publications and helpful links

General Publications

• Lee J, Lee CW, Jang Y, You JS, Park YS, Ji E, Yu H, Oh S, Ryoo HA, Cho N, Park JY, Yoon J, Baek JH, Park HY, Ha TH, Myung W. Efficacy and safety of daily home-based transcranial direct current stimulation as adjunct treatment for bipolar depressive episodes: Double-blind sham-controlled randomized clinical trial. Front Psychiatry. 2022 Sep 20;13:969199. doi: 10.3389/fpsyt.2022.969199. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 25, 2019
• Primary Completion (ANTICIPATED): June 30, 2020
• Study Completion (ANTICIPATED): October 30, 2020

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (ACTUAL): June 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Depression; tDCS; Bipolar disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Bipolar and Related Disorders; Depression; Bipolar Disorder
• Other Study ID Numbers: YB_ST_IIT1901

Drug and device information, study documents

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