Transcranial Direct Current Stimulation (tDCS) in Young Individuals With Major Depressive Disorder: a Literature Review and Feasibility Study
NCT Number: NCT06518642
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depressive Disorder
Interventions: DEVICE: Sooma tDCS portable device - active stimulation|DEVICE: Sooma tDCS portable device - sham stimulation
Sponsor: The University of Hong Kong
Sex: ALL
Age: CHILD, ADULT
Enrollment: 8
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-22
Completion Date: 2024-03-31
Locations: University of Hong Kong, Hong Kong, Hong Kong

Summary:
Objectives: (1) To assess the therapeutic effects of tDCS on improving depressive symptoms in young individuals with Major Depressive Disorder (MDD), relative to sham stimulation ; and (2) to evaluate the tolerability, and feasibility of tDCS in young individuals with Major Depressive Disorder, to explore the feasibility for a scale-up study.

Hypothesis: 1) we hypothesize the tDCS stimulation of the dorsolateral prefrontal cortex (dLPFC) will reduce symptoms of depression more than sham stimulation, demonstrated by significant difference in change of Hamilton Depression Rating Scale (HDRS) and 2) tDCS active stimulation of the dLPFC will be tolerable and feasible among patients with MDD, as demonstrated by minimal adverse effects measured in the Adverse Events Questionnaire, adherence (with reasons of drop out), their motivation and enjoyment to participate in the study .

Primary Outcome Measures: Hamilton Depression Rating Scale (HDRS) - 17 items, Measuring depressive symptoms, score ranges from 0 (minimum) to 53 (maximum); higher score indicates more severe depressive symptoms., T0 (baseline); T1 (immedately after intervention)
Secondary Outcome Measures: Social and Occupational Functioning Assessment scale (SOFAS), Measures social and occupational functioning across work functioning, independent functioning, immediate and extended social network functioning; score ranges from 0 (minimum) to 100 (maximum), higher score indicates higher social and occupational functioning ability., T0 (baseline); T1 (immedately after intervention)|Role Functioning Scale (RFS), Measures role functioning in four areas: work productivity, independent living, immediate and extended social network relationships; score ranges from 0 (minimum) to 7 (maximum) on each aspect, higher score indicates better role functioning, T0 (baseline); T1 (immedately after intervention)|Global Functioning: Social Scale and Role Scale, Measures social and role functioning; score ranges from 1 (minimum) to 10 (maximum); higher score indicates better social/role functioning, T0 (baseline); T1 (immedately after intervention)|Short Form Health Survey (SF-12), Short-form measure of health status with 12 questions., T0 (baseline); T1 (immedately after intervention)|Clinical Global Impression Scale, Measures the severity of illness and global improvement following an intervention; scores ranges from 1 (normal/very much improved) to 7 (most severely ill/very much worse), with higher scores indicating worse outcome., T1 (immedately after intervention)|Beck Scale of Suicidal Ideation., Measures self-reported suicidal ideation; score ranges from 0 (minimum) to 38 (maximum), with higher scores indicating a greater risk of suicide., T0 (baseline); T1 (immedately after intervention)|Visual Analog Scale (VAS), Two VASs were used to measure motivation and willingness during intervention. Each VAS contains a scale of 0 (minimum) to 10 (maximum) with higher scores indicating more, T0 (baseline); T1 (immedately after intervention)|Chinese version of the Snaith-Hamilton Pleasure Scale (C-SHAPS), Gold standard, self-rated scale measuring anhedonia symptoms. Each item ranges from 0 to 3, hence total score ranges from 0 (minimum) to 42 (maximum) with higher scores indicating more anhedonic symptoms, T0 (baseline); T1 (immedately after intervention)|Chinese version of the Dimensional Anhedonia Rating Scale (C-DARS), 17-item self-rated questionnaire measuring anhedonia symptoms. Each item ranges from 0 to 4, hence total score ranges from 0 (minimum) to 68 (maximum) with higher scores indicating lower levels of anhedonia symptoms, T0 (baseline); T1 (immedately after intervention)|Adherence rate to the participation of the tDCS study, Adherence rate of full participation in each tDCS session; and the reason of skipping the tDCS session if any, from T0 (baseline) to T1 (immedately after intervention)