HD-tDCS for Adolescent Bipolar Depression Targeting S1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorJiangsu Province Nanjing Brain Hospital
About this trial
This randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression. Participants will be randomly assigned to receive either active HD-tDCS or sham stimulation, in addition to routine clinical care. Biological data, including neuroimaging, blood biomarkers, voice and facial features, Photoplethysmography (PPG), Electroencephalography (EEG), and behavioral data, will be collected to explore potential predictors of treatment response.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between 12 and 18 years of age;
Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for bipolar disorder (BD). Participants are assessed by the Structured Clinical Interview for DSM-IV for Axis I Disorders (SCID-I, patients' age ≥18 years old), or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K- SADS-PL, patients' age< 18 years old);
A current moderate or severe depressive episode defined by HAMD≥17 and Young Mania Rating Scale (YMRS) <12;
Participants receive a stable psychotropic medication regimen prior to randomization to the trial and are willing to remain on the stable regimen during the HD-tDCS treatment phase;
Disqualifiers
Prior rTMS or tDCS or electroconvulsive therapy (ECT) treatment or standard psychological therapy within 6 months prior to screening;
Comorbidity of other DSM-IV axis I disorders or personality disorders;
Judged clinically to be at serious suicidal risk;
Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities;
Trial design
Design model
Parallel
Treatments tested in this trial
Active HD-tDCS
DeviceHD-tDCS is a non-invasive neuromodulation therapy which has been recognized as a helpful treatment for depression. During each HD-tDCS treatment, the electrode field is generated by a 4\*1 ring montage which is placed over the scalp on the brain region of interest with an electrical current induced to modulate brain activity.
Antipsychotics, mood stabilizers, etc.
DrugDuring the HD-tDCS treatment period, all the participants will maintain the stable medication regimen according to clinical practice guidelines.
Sham HD-tDCS
DeviceSham HD-tDCS is administered using the same electrode configuration as the active HD-tDCS condition. During each session, the device ramps up current briefly (typically 30 seconds) to mimic the initial sensation of stimulation, then remains off for the remainder of the 20-minute session. This method produces the same tactile perception as active stimulation without delivering a therapeutic dose of current.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Active HD-tDCS Targeting Right S1Experimental treatment 2 interventions
Group B: Sham Stimulation at Right S1Sham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in depressive symptoms assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at Week 2.
The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 17 or higher indicate moderate, severe, or very severe depression.
Time frame
Baseline and after 2 weeks.Secondary outcomes
1
Change from baseline in depressive symptoms assessed by HAMD-17 after week 1.
The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 17 or higher indicate moderate, severe, or very severe depression.
Time frame
Baseline and after 1 week.2
Change in anxiety symptoms assessed by Hamilton Anxiety Rating Scale (HAMA) after week 1 and after week 2.
The HAMA consists of 14 items designed to assess the severity of a patient's anxiety. Each item is rated on a scale of 0 (not present) to 4 (severe), with a total score ranging from 0 to 56. Higher scores indicate greater anxiety. Change in total score from baseline will be calculated.
Time frame
Baseline, after 1week and after 2 weeks.3
Change from baseline in the Clinical Global Impression-Severity scale (CGI-S) after week 1 and after week 2.
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
Time frame
Baseline and after 1 week and after 2 weeks.4
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) after 1 week and after 2 week.
MADRS is a clinician-rated scale used to assess depressive symptom severity and detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is rated from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). The total score of MADRS ranges from 0 to 60, with higher score indicating more severe depression.
Time frame
Baseline, after 1 week and after 2 weeks.Sponsors and contacts
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Source ClinicalTrials.gov