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

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ClinicalTrials.gov Identifier: NCT03974815
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Ybrain Inc.
Information provided by (Responsible Party):
Woojae Myung, 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.


Condition or disease Intervention/treatment Phase
tDCS Device: ACTIVE Device: SHAM Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Active stimulation group: 2mA, 30min (1min ramping up/down) Sham stimulation group: 0mA, 30min (1min ramping up/down)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Augmentative Transcranial Direct Current Stimulation (tDCS) in Patients With Bipolar Depression: RCT, IIT Study.
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The changes in HAM-D [ Time Frame: 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.

  2. Response rate of treatment [ Time Frame: baseline, 6week ]
    Response group: Reduce of HAM-D 50%


Secondary Outcome Measures :
  1. HAM-A [ Time Frame: 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

  2. YMRS [ Time Frame: 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.

  3. CGI-BP [ Time Frame: baseline, 2week, 4week, 6week ]
    Clinical Global Impression- Bipolar

  4. Q-LES-Q-SF [ Time Frame: baseline, 2week, 4week, 6week ]
    Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form


Other Outcome Measures:
  1. qEEG [ Time Frame: baseline, 2week ]
    The changes of qEEG analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (lithium or valproic acid) for at least four weeks before the day of screening, and whose blood concentration of the mood stabilizer during screening and baseline visits satisfies the following below.
  • Lithium: 0.6 ~ 1.2 mEq/L
  • Valproxane: 50 ~125μg/mL

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.
  • medical history of suicide attempts, serious suicide risk as determined by clinicians, and psychopathic symptoms
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974815


Locations
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Korea, Republic of
Seoul National University Boondang Hospital Recruiting
Seongnam-si, Boondang, Gyunggi, Korea, Republic of, 13620
Contact: Woojae Myung, MD, PhD    +82)31-787-2720    smbhealer@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Ybrain Inc.

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Responsible Party: Woojae Myung, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03974815     History of Changes
Other Study ID Numbers: YB_ST_IIT1901
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Woojae Myung, Seoul National University Hospital:
tDCS
Bipolar disorder
Depression

Additional relevant MeSH terms:
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Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders