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

tDCS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03974815
• Other study ID #: YB_ST_IIT1901
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: December 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• tDCS

Intervention

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
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Boondang Hospital	Seongnam-si	Boondang, Gyunggi

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ybrain Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	qEEG	The changes of qEEG analysis	baseline, 2week
Primary	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
Primary	Response rate of treatment	Response group: Reduce of HAM-D 50%	baseline, 6week
Secondary	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
Secondary	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
Secondary	CGI-BP	Clinical Global Impression- Bipolar	baseline, 2week, 4week, 6week
Secondary	Q-LES-Q-SF	Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form	baseline, 2week, 4week, 6week