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

Not Applicable

• Conditions: tDCS
• Interventions: Device: SHAM; Device: ACTIVE

• Registration Number: NCT03974815
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-05
• Study Start: 2019-06-25
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-23
• Last Update Posted: 2019-12-26
• Primary Completion: 2020-06-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM	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)
ACTIVE	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)

Primary Outcome Measures

Name	Time	Method
Response rate of treatment	baseline, 6week	Response group: Reduce of HAM-D 50%
The changes in HAM-D	baseline, 2week, 4week, 6week	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.

Secondary Outcome Measures

Name	Time	Method
CGI-BP	baseline, 2week, 4week, 6week	Clinical Global Impression- Bipolar
HAM-A	baseline, 2week, 4week, 6week	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
YMRS	baseline, 2week, 4week, 6week	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.
Q-LES-Q-SF	baseline, 2week, 4week, 6week	Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

Trial Locations

Locations (1)

Seoul National University Boondang Hospital; 🇰🇷 Seongnam-si, Boondang, Gyunggi, Korea, Republic of