Transcranial Direct Current Stimulation for Depression
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Second Hospital of Anhui Medical University
About this trial
Background:
Depression is a common mental disorder characterized by persistent low mood and anhedonia. Pharmacological and psychotherapeutic treatments demonstrate only moderate efficacy. Non-invasive brain stimulation techniques offer novel therapeutic approaches. Among these, transcranial direct current stimulation (tDCS) holds advantages due to its simplicity, low cost, and minimal side effects, exhibiting good efficacy and tolerability in depression treatment. The dorsolateral prefrontal cortex (DLPFC), a core region of the cognitive control network, serves as a traditional target for non-invasive brain stimulation in depression and plays a crucial role in positive affect (PA) processing. Conversely, the dorsomedial prefrontal cortex (DMPFC), a central region of the default mode network, participates in negative self-referential processing and negative affect (NA) regulation, demonstrating potential as a novel therapeutic target.
Objective:
Given the distinct roles of DLPFC and DMPFC in separate affective regulation networks, this study aims to investigate the differential effects of different tDCS targets on emotional regulation in patients with depression.
Design:
This study employed a randomized, double-blind, controlled design. Participants diagnosed with depression will be randomly assigned to receive either effective tDCS targeting the left DLPFC or effective tDCS targeting the DMPFC. Primary outcome measures focus on changes in clinical symptom assessments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The diagnosis meets the criteria for depression outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Age between 18 and 65 years.
Education level exceeding 5 years, with no significant hearing or visual impairments.
Voluntary signing of informed consent and ability to cooperate with general demographic data collection and neuropsychological scale testing.
Disqualifiers
Age under 18 or over 65.
Patients with neurological disorders such as epilepsy or severe physical illnesses.
Patients with comorbid neuropsychiatric disorders, such as schizophrenia or obsessive-compulsive disorder.
Patients unable to undergo tDCS treatment for any reason, including presence of ferromagnetic metal in the head or implanted medical devices in the head/neck region.
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial direct current stimulation (tDCS)
DeviceStimulation was delivered using a high-precision transcranial direct current stimulation (tDCS) device (Soterix Medical, Inc., New York, USA) via five small electrode pads (1 cm × 1 cm) arranged in a 4×1 ring configuration.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: DLPFC groupActive comparator 1 intervention
Group B: DMPFC groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
17-item Hamilton Depression Rating Scale (HAMD)
Improvement in HAMD scores following transcranial direct current stimulation (tDCS) treatment (The HAMD consists of 17 items, with a total score ranging from 0 to 53; a higher score indicates more severe depressive symptoms).
Time frame
Baseline, immediately after all intervention, and follow-up after all intervention (1 month).2
Positive and Negative Affect Schedule (PANAS)
The degree of improvement in PANAS scores following transcranial direct current stimulation (used to assess patients' positive and negative emotions; consisting of 20 items, with 10 items representing positive emotions; the total positive emotion score ranges from 0 to 50, with higher scores indicating greater vitality and enthusiasm; the other 10 items represent negative emotions, with the total negative emotion score ranging from 0 to 50; higher scores indicate stronger negative emotions).
Time frame
Baseline and immediately after all intervention.Secondary outcomes
1
Self-Rating Depression Scale (SDS)
Improvement in SDS (SDS comprises 20 items with a total score range of 0-100; higher scores indicate more severe depressive symptoms) scores following transcranial direct current stimulation treatment.
Time frame
Baseline and immediately after all intervention.2
Hamilton Anxiety Rating Scale (HAMA)
Improvement in HAMA (HAMA comprises 14 items with a total score range of 0-56; higher scores indicate more severe anxiety symptoms) scores following transcranial direct current stimulation treatment.
Time frame
Baseline and immediately after all intervention.3
15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15)
Improvement in PHQ-15(comprising 15 items with a total score of 30; higher scores indicate more severe somatization symptoms) scores following transcranial direct current stimulation treatment.
Time frame
Baseline and immediately after all intervention.4
Insomnia Severity Index (ISI)
Improvement in ISI(comprising 7 items with a total score of 28; higher scores indicate more severe insomnia) scores following transcranial direct current stimulation treatment.
Time frame
Baseline and immediately after all intervention.Sponsors and contacts
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Source ClinicalTrials.gov