Clinical trial NCT02657980: The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder
Official title: The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
tDCS
MDD
transcranial Direct Current Stimulation
Lead sponsor: Ybrain Inc.
Sponsor class: INDUSTRY
Collaborators: name: Severance Hospital
name: Gangnam Severance Hospital
name: Myongji Hospital
name: CHA University
name: National Health Insurance Service Ilsan Hospital
name: Ajou University
name: Hallym University Medical Center
First posted: 2016-01-18
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Detailed description: Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week for 2 weeks. They will be evaluated every 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features)
* Greater than 22 points of Montgomery-Asberg Depression Rating Scale
* Aged 19 to 65.
* Has provided informed consent

Exclusion Criteria:

* Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.)
* History of suicidal attempt in the last 6 months
* Diagnosed with bipolar or psychotic major depressive disorder
* Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
* Has hypersensitivity to sertraline ingredients
* A score of 5 or greater for the question #10 in MADRS
* Diagnosed with closed angle glaucoma or has a history of glaucoma.
* History of participation in other clinical trials within 30days.
* A major and/or unstable medical or neurologic illness
* Currently taking substances that contain sertraline, mono amine oxidase inhibitor, or pimozide
* Pregnant or has a positive pregnancy serum test.

Primary outcomes:
measure: Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: from baseline to Week 6
Secondary outcomes:
measure: Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: At 6 weeks after treatment.
measure: Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: At 6 weeks after treatment
measure: Average change in results for 2, 4, 6 weeks after treatment as assessed by the clinician-rated Clinical Global Impression-Severity of Illness Scale (CGISI)
timeFrame: At 2 weeks, 4 weeks and 6 weeks after treatment
measure: Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II)
timeFrame: At 2 weeks, 4 weeks and 6 weeks after treatment
measure: Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI)
timeFrame: At 2 weeks, 4 weeks and 6 weeks after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ybrain
Study officials:
affiliation: Ybrain Company
name: Seungwoo Lee
role: STUDY_DIRECTOR
References: