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

NCT03974815 | Unknown

• 1 other identifier: YB_ST_IIT1901
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

tDCS

Keywords

tDCS; Bipolar disorder; Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• HAM-A

  baseline, 2week, 4week, 6week

• YMRS

  baseline, 2week, 4week, 6week

• CGI-BP

  baseline, 2week, 4week, 6week

• Q-LES-Q-SF

  baseline, 2week, 4week, 6week

Other Outcomes (1)

• qEEG

  baseline, 2week

Study Arms (2)

ACTIVE

EXPERIMENTAL

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

SHAM

SHAM COMPARATOR

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

Interventions

ACTIVE DEVICE

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.

ACTIVE

SHAM DEVICE

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.

SHAM

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ybrain Inc.: collaborator

Study Sites (1)

Seoul National University Boondang Hospital

Seongnam-si, Boondang, Gyunggi, 13620, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 36203828 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Active stimulation group: 2mA, 30min (1min ramping up/down) Sham stimulation group: 0mA, 30min (1min ramping up/down)

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: June 25, 2019
• Primary Completion: June 30, 2020
• Study Completion: October 30, 2020
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

KR (1)