Major Depressive EpisodePRHDTDCSTMDENCT05498441
Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Treatment for Major Depressive Episode
A study testing High-Definition Transcranial Direct Current Stimulation (HD-tDCS) and Antipsychotics, mood stabilizers, etc. in people with Major Depressive Episode, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
Trial summary
Adolescents with mood disorders experiencing major depressive episode have poor efficacy of medication treatment. High-Definition Transcranial Direct Current Stimulation (HD-tDCS) has been proven adjuvant efficacy in patients with major depressive episode. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- High-Definition Transcranial Direct Current Stimulation (HD-tDCS) and Antipsychotics, mood stabilizers, etc.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 13 and 18 years of age;
- Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for major depressive disorder (MDD) or bipolar disorder (BD);
- Participants are assessed by the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL);
- A current moderate or severe depressive episode defined by HAMD>17;
- Participants receive a stable psychotropic medication regimen prior to randomization to the trial and patient will be willing to remain on the stable regimen during the HD-tDCS treatment phase;
- All participants provided written informed consent by themselves or their guardians after the detailed description of the study.
Who cannot join
- Prior rTMS, tDCS, electroconvulsive therapy (ECT) application 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;
- Unstable medical conditions, e.g., severe asthma;
- Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases;
Show all 9Show fewer
- Mental retardation or autism spectrum disorder;Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metalimplants);
- Contraindications to HD-tDCS (e.g., scalp rupture, cranial plates, history of seizure,electroencephalogram (EEG) test suggesting high risk of seizure, known brain lesion);
- Current drug/alcohol abuse or dependence;Pregnant or lactating female.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Nanjing Brain Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000
Fei Wang, 86-025-83295957, fei.wang@yale.edu
Juan Liu, 86-15189204675, zhangzhongguo@163.com
About this study
Official title: Neuroimaging Biomarker-guided Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Treatment for Major Depressive Episode in Adolescents With Mood Disorders: A Randomized Controlled Study
Adolescents with mood disorders experiencing major depressive episode have poor efficacy of medication treatment. High-Definition Transcranial Direct Current Stimulation (HD-tDCS) has been proven adjuvant efficacy in patients with major depressive episode. However, the optimal evidence-based stimulation parameters have not been clearly defined, which greatly limits the efficacy of HD-tDCS in the treatment of major depressive episode.This trial will compare a novel form of accurate and personalized HD-tDCS treatment protocol guided by neuroimaging biomarkers to the routine stimulation(stimulation target is L-DLPFC, central electrode is anode).The personalized selection of stimulation site, central electrode polarity will be determined by neuroimaging biomarkers. The study aims to propose a novel personalized neuroimaging-guided HD-tDCS strategy, to evaluate the efficacy and safety of the treatment, further to understand the biological mechanism of the personalized HD-tDCS treatment.
Read the detailed description
Mood disorders, including mainly bipolar disorder (BD) and major depressive disorder (MDD), have become the primary health problem and one of the leading causes of functional disability in adolescents . In China, the incidence of mood disorders such as BD and MDD in adolescence has increased rapidly in recent years. Particularly, patients with mood disorder currently experiencing major depressive episode have high risk of suicide, and pharmacological treatment showed poor efficacy to such depressive patients. Mood disorders with major depressive episode have become one of the major threats to the mental health of adolescents in China. Therefore, it is of great significance to explore a series of early intervention strategies for adolescents with major depressive episode. HD-tDCS is a non-invasive brain stimulation treatment strategy with mild side effects. The set of stimulation parameters often has a vital impact on the final clinical efficacy of HD-tDCS treatment. Several clinical trials have reported the efficacy and safety of HD-tDCS on treatment major depression disorder. However, the evidence-based optimal targets and other stimulation parameters have not been clearly defined, which greatly limits the efficacy of HD-tDCS in the treatment of major depressive episode. To date, there is no large randomized clinical trial (RCT) exploring an optimization of HD-tDCS on adolescents with major depressive episode. This study is a randomized controlled trial aiming at assessing the efficacy and safety of a novel personalized HD-tDCS treatment protocol compared to routine stimulation for major depressive episode in adolescents with mood disorders. Participants will be assigned randomly (1:1) to the personalized HD-tDCS group or the routine HD-tDCS group. Participants will be treated with 20 sessions (2 sessions per day) HD-tDCS treatment. The stimulation parameters of routine HD-tDCS group are: current=2 mA, duration=20 min, stimulation target=L-DLPFC, central electrode=anode. The stimulation parameters of personalized HD-tDCS group are current=2 mA and duration=20 min, while the stimulation target and central electrode polarity are based on neuroimaging biomarkers extracted via machine learning. Participants in both groups will maintain the stable drug regimen during the HD-tDCS trial.
- Conditions
- Major Depressive Episode
- Being tested
- High-Definition Transcranial Direct Current Stimulation (HD-tDCS), Antipsychotics, mood stabilizers, etc.
- Keywords
- High-Definition Transcranial Direct Current Stimulation, Major Depressive Episode, Magnetic Resonance Imaging, Adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS)Device
High-Definition Transcranial Direct Current Stimulation (HD-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.Drug
During the HD-tDCS treatment period, all the participants will maintain the stable medication regimen according to clinical practice guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Personalized HD-tDCS | Experimental | The experimental arm will receive the personalized HD-tDCS treatment with parameters as follows:
1. Neuroimaging biomarker-guided personalized selection for central electrode polarity: anode or cathodal;
2. Neuroimaging biomarker-guided personalized selection for stimulation site: dorsalmedial prefrontal cortex or occipital cortex;
3. Schedule: 2 sessions per day, five days per week for a total of 20 sessions over 2 weeks. Receives: Device: High-Definition Transcranial Direct Current Stimulation (HD-tDCS); Drug: Antipsychotics, mood stabilizers, etc. |
| Routine HD-tDCS | Active comparator | Routine stimulation arm will receive the same scheme of HD-tDCS, but the stimulation target is L-DLPFC with anode as central electrode. Receives: Device: High-Definition Transcranial Direct Current Stimulation (HD-tDCS); Drug: Antipsychotics, mood stabilizers, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depressive symptoms assessed by Hamilton depression rating scale 17 items (HAMD-17) at week 1 and 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.
Measured: Baseline, week 1 and week 2
Change from baseline in neurocognitive function using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test at week 2.
RBANS is a test for identifying and characterizing abnormal cognitive decline for patients with neuropsychiatric disorders. The RBANS is comprised of five domains, which are Immediate Memory, Visuospatial /Constructional,Language, Attention and Delayed Memory. The total score of RBANS range from 40-160, with 160 referring to higher cognitive functioning. A score of 95-115 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.
Measured: Baseline and week 2.
Change from baseline in resting-state magnetic resonance imaging (MRI) , diffusion tensor imaging (DTI) and structural (T1-weighted) imaging at weeks 1 and 2.
Participants will undergo MRI scans prior to beginning HD-tDCS treatment (week 0) and after completing 10 sessions of HD-tDCS treatment (weeks 1) and after completing 20 sessions of HD-tDCS treatment (weeks 2). This allows for a comprehensive examination of changes from baseline in functional activity, DTI and structural changes in the brain at weeks 1 and 2.
Measured: Baseline, week 1 and week 2.
Secondary outcomes (24)
Change from baseline in the Clinical Global Impression-Severity scale (CGI-S) at week 1 and 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.
Measured: Baseline, week 1 and week 2.
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) at week 1 and week 2.
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.
Measured: Baseline, week 1 and week 2.
Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at baseline, week 1 and week 2.
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-27) depression.
Measured: Baseline, week 1 and week 2.
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at baseline, week 1 and week 2.
The total scores of these questionnaires were interpreted as follows: normal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety.
Measured: Baseline, week 1 and week 2.
Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at baseline, week 1 and week 2.
The total scores of these questionnaires were interpreted as follows: normal (0-7), mild (8-14), moderate (15-21), and severe (22-28) insomnia.
Measured: Baseline, week 1 and week 2.
Change from baseline in suicidal ideation assessed by the Beck Scale for Suicide (BSS-14; range: 0-38) at baseline, week 1 and week 2.
The total scores of these questionnaires were interpreted as follows: no or low suicidal ideation (0-8), moderate suicidal ideation (9-16), high suicidal ideation (17-38).
Measured: Baseline, week 1 and week 2.
Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at baseline, week 1 and week 2.
The total scores of these questionnaires were interpreted as follows: normal (0-28), moderate (29-42), severe (43-56).
Measured: Baseline, week 1 and week 2.
Change from baseline in neurocognitive function using Wsiconsin card sorting test (WCST) at week 2.
The Wisconsin Card Sorting Test measures the ability to categorize, generalize, working memory, and cognitive transfer based on previous experience. Cognitive functions reflected include: abstract generalization, cognitive transfer, attention, working memory, information extraction, categorization maintenance, categorization switching, stimulus reconsideration and processing, sensory input, and motor output.
Measured: Baseline and week 2.
Change from baseline in neurocognitive function using Verbal Emotion Perception Test (VEPT) at week 2.
VEPT can be used to identify the patient's ability to perceive emotions contained in speech, including the seven emotions of calmness, anger, sadness, fear, surprise, sarcasm, and disgust.
Measured: Baseline and week 2.
Change from baseline in neurocognitive function using Facial Emotion Perception Test (FEPT) at week 2.
The FEPT can be used to recognize a patient's ability to perceive the emotions contained in a face, including the seven emotions of calmness, anger, disgust, fear, happiness, sadness, and surprise.
Measured: Baseline and week 2.
Change from baseline in acoustic features.
Participants will record videos prior to beginning intervention (baseline) and after completing intervention (week 1, week 2). Acoustic features (Hz) are a set of indicators that can reflect an individual's emotional state.
Measured: Baseline, week 1 and week 2.
Change from baseline in manic symptoms assessed by the Young Manic Rating Scale(YMRS) at baseline, week 1 and week 2. scales.
The total scores of these questionnaires were interpreted as follows: normal (0-5), mild (6-12), moderate (13-19), and severe (20-29) manic.
Measured: Baseline, week 1 and week 2.
Changes from metabolites in peripheral blood.
Peripheral blood samples were collected from all participants at baseline, week 1 and week 2. Plasma samples were obtained and stored at -80°C. We will conducted untargeted metabolomics analysis to obtained metabolomic data. Metabolomics is the scientific study of chemical processes involving metabolites, the small molecule substrates, intermediates, and products of cell metabolism.
Measured: Baseline, week 1 and week 2.
Changes from protein samples in peripheral blood.
Peripheral blood samples were collected from all participants at baseline, week 1 and week 2. Data Independent Acquisition (DIA) mass spectrometry methods were employed to acquire and analyze protein samples. High- and low-abundance proteins are collected and digested into peptides using the Agilent Multiple Affinity Removal System and Filter-Assisted Sample Preparation (FASP). Data dependent acquisition (DDA) mass spectrometry analysis was then performed by Q-Exactive HF-X mass spectrometry to generate DDA libraries.
Measured: Baseline, week 1 and week 2.
Changes from methylation in peripheral blood.
Peripheral blood samples were collected from all participants at baseline, week 1 and week 2. Epigenetics data were obtained by processing DNA samples and hybridizing them to the Illumina Infinium Methylation EPIC BeadChip, which enables quantitative assessment of over 850,000 methylation sites across the genome at single-nucleotide resolution, following the Infinium HD Methylation Assay Protocol.
Measured: Baseline, week 1 and week 2.
Electroencephalogram - delta waves (0.5-4 Hz)
We collecte brainwave frequencies including delta waves (0.5-4 Hz), theta waves (4-8 Hz), alpha waves (8-13 Hz), beta waves (13-30 Hz), and gamma waves (above 30 Hz).
Delta Waves (0.5-4 Hz) are typically recorded during deep sleep. EEG recordings are made using electrodes placed on the scalp while the person is sleeping, preferably during non-REM (rapid eye movement) sleep stages.
Measured: Baseline
Electroencephalogram - theta waves (4-8 Hz)
We collecte brainwave frequencies including delta waves (0.5-4 Hz), theta waves (4-8 Hz), alpha waves (8-13 Hz), beta waves (13-30 Hz), and gamma waves (above 30 Hz).
Theta Waves (4-8 Hz) are commonly observed during light sleep and the early stages of sleep. EEG recordings are made in a similar way to delta waves, during sleep stages where theta activity is predominant.
Measured: Baseline
Electroencephalogram - alpha waves (8-13 Hz)
We collecte brainwave frequencies including delta waves (0.5-4 Hz), theta waves (4-8 Hz), alpha waves (8-13 Hz), beta waves (13-30 Hz), and gamma waves (above 30 Hz).
Alpha Waves (8-13 Hz) are most prominent when a person is awake but relaxed, with eyes closed. EEG electrodes are placed on the scalp during a relaxed state, such as during meditation or when a person is awake but resting.
Measured: Baseline
Electroencephalogram - Beta Waves (13-30 Hz)
We collecte brainwave frequencies including delta waves (0.5-4 Hz), theta waves (4-8 Hz), alpha waves (8-13 Hz), beta waves (13-30 Hz), and gamma waves (above 30 Hz).
Beta Waves (13-30 Hz)are observed when a person is awake and engaged in mental activities, such as problem-solving or active thinking. EEG recordings are made during tasks that require concentration and mental effort.
Measured: Baseline
Electroencephalogram- gamma waves (above 30 Hz)
We collecte brainwave frequencies including delta waves (0.5-4 Hz), theta waves (4-8 Hz), alpha waves (8-13 Hz), beta waves (13-30 Hz), and gamma waves (above 30 Hz).
Gamma Waves (Above 30 Hz) are the fastest documented brain wave activity and are often associated with higher mental activities such as perception and consciousness. They are recorded using advanced EEG techniques and are typically observed during complex cognitive tasks.
Measured: Baseline
Change from baseline in psychotic symptoms assessed by the Brief Psychiatric Rating Scale (BPRS) at baseline, week 1 and week 2. scales.
The total scores of these questionnaires were interpreted as follows: normal (0-35) and abnormal (>35) .
Measured: Baseline, week 1 and week 2.
Change from baseline in anxious symptoms assessed by the Hamilton anxiely scale (HAMA) at baseline, week 1 and week 2. scales.
The total scores of these questionnaires were interpreted as follows: normal (0-7), mild (8-14), moderate (15-21), and severe (22-28) manic.
Measured: Baseline, week 1 and week 2.
Change from baseline in anhedonia symptoms assessed by the Snaith-Hamilton Pleasure Scale(SHAPS) at baseline, week 1 and week 2.
The total scores of these questionnaires were interpreted as follows: normal (0-7) and abnormal (>7) .
Measured: Baseline, week 1 and week 2.
Change from baseline in anhedonia symptoms assessed by the Temporal Experience of Pleasure Scale (TEPS) at baseline, week 1 and week 2.
The scale consists of two subscales: Anticipatory Pleasure and Consummatory Pleasure, each containing 18 items. The total scores for Anticipatory Pleasure and Consummatory Pleasure range from 0 to 54, with higher scores indicating a richer experience of pleasure. Generally, higher total scores are considered meaningful, while lower scores may indicate a decrease or lack of pleasure experiences.
Measured: Baseline, week 1 and week 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Wang, Study chair, Affiliated Nanjing Brain Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498441
- Sponsor's protocol ID
- 81725005-3
- Acronym
- PRHDTDCSTMDE
- Status last verified
- Sep 2023
- First submitted
- 10 Aug 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Biomarker-guided Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Treatment for Major Depressive Episode in Adolescents With Mood Disorders: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05498441
- Acronym / sponsor ID
- PRHDTDCSTMDE / 81725005-3
- Conditions
- Major Depressive Episode
- Keywords
- High-Definition Transcranial Direct Current Stimulation, Major Depressive Episode, Magnetic Resonance Imaging, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescents with mood disorders experiencing major depressive episode have poor efficacy of medication treatment. High-Definition Transcranial Direct Current Stimulation (HD-tDCS) has been proven adjuvant efficacy in patients with major depressive episode. However, the optimal evidence-based stimulation parameters have not been clearly defined, which greatly limits the efficacy of HD-tDCS in the treatment of major depressive episode.This trial will compare a novel form of accurate and personalized HD-tDCS treatment protocol guided by neuroimaging biomarkers to the routine stimulation(stimulation target is L-DLPFC, central electrode is anode).The personalized selection of stimulation site, central electrode polarity will be determined by neuroimaging biomarkers. The study aims to propose a novel personalized neuroimaging-guided HD-tDCS strategy, to evaluate the efficacy and safety of the treatment, further to understand the biological mechanism of the personalized HD-tDCS treatment.
Detailed description
Mood disorders, including mainly bipolar disorder (BD) and major depressive disorder (MDD), have become the primary health problem and one of the leading causes of functional disability in adolescents . In China, the incidence of mood disorders such as BD and MDD in adolescence has increased rapidly in recent years. Particularly, patients with mood disorder currently experiencing major depressive episode have high risk of suicide, and pharmacological treatment showed poor efficacy to such depressive patients. Mood disorders with major depressive episode have become one of the major threats to the mental health of adolescents in China. Therefore, it is of great significance to explore a series of early intervention strategies for adolescents with major depressive episode. HD-tDCS is a non-invasive brain stimulation treatment strategy with mild side effects. The set of stimulation parameters often has a vital impact on the final clinical efficacy of HD-tDCS treatment. Several clinical trials have reported the efficacy and safety of HD-tDCS on treatment major depression disorder. However, the evidence-based optimal targets and other stimulation parameters have not been clearly defined, which greatly limits the efficacy of HD-tDCS in the treatment of major depressive episode. To date, there is no large randomized clinical trial (RCT) exploring an optimization of HD-tDCS on adolescents with major depressive episode. This study is a randomized controlled trial aiming at assessing the efficacy and safety of a novel personalized HD-tDCS treatment protocol compared to routine stimulation for major depressive episode in adolescents with mood disorders. Participants will be assigned randomly (1:1) to the personalized HD-tDCS group or the routine HD-tDCS group. Participants will be treated with 20 sessions (2 sessions per day) HD-tDCS treatment. The stimulation parameters of routine HD-tDCS group are: current=2 mA, duration=20 min, stimulation target=L-DLPFC, central electrode=anode. The stimulation parameters of personalized HD-tDCS group are current=2 mA and duration=20 min, while the stimulation target and central electrode polarity are based on neuroimaging biomarkers extracted via machine learning. Participants in both groups will maintain the stable drug regimen during the HD-tDCS trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized HD-tDCS | Experimental | Device: High-Definition Transcranial Direct Current Stimulation (HD-tDCS), Drug: Antipsychotics, mood stabilizers, etc.The experimental arm will receive the personalized HD-tDCS treatment with parameters as follows: 1. Neuroimaging biomarker-guided personalized selection for central electrode polarity: anode or cathodal; 2. Neuroimaging biomarker-guided personalized selection for stimulation site: dorsalmedial prefrontal cortex or occipital cortex; 3. Schedule: 2 sessions per day, five days per week for a total of 20 sessions over 2 weeks. |
| Routine HD-tDCS | Active comparator | Device: High-Definition Transcranial Direct Current Stimulation (HD-tDCS), Drug: Antipsychotics, mood stabilizers, etc.Routine stimulation arm will receive the same scheme of HD-tDCS, but the stimulation target is L-DLPFC with anode as central electrode. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Between 13 and 18 years of age;
- Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for major depressive disorder (MDD) or bipolar disorder (BD);
- Participants are assessed by the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL);
- A current moderate or severe depressive episode defined by HAMD>17;
- Participants receive a stable psychotropic medication regimen prior to randomization to the trial and patient will be willing to remain on the stable regimen during the HD-tDCS treatment phase;
Key exclusion criteria (9 listed)
- Prior rTMS, tDCS, electroconvulsive therapy (ECT) application 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;
- Unstable medical conditions, e.g., severe asthma;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Definition Transcranial Direct Current Stimulation (HD-tDCS)High-Definition Transcranial Direct Current Stimulation (HD-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. | Device | Personalized HD-tDCS, Routine HD-tDCS |
| Antipsychotics, mood stabilizers, etc.During the HD-tDCS treatment period, all the participants will maintain the stable medication regimen according to clinical practice guidelines. | Drug | Personalized HD-tDCS, Routine HD-tDCS |
Primary outcome
Change from baseline in depressive symptoms assessed by Hamilton depression rating scale 17 items (HAMD-17) at week 1 and week 2.
Time frame: Baseline, week 1 and 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.
Change from baseline in neurocognitive function using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test at week 2.
Time frame: Baseline and week 2.
RBANS is a test for identifying and characterizing abnormal cognitive decline for patients with neuropsychiatric disorders. The RBANS is comprised of five domains, which are Immediate Memory, Visuospatial /Constructional,Language, Attention and Delayed Memory. The total score of RBANS range from 40-160, with 160 referring to higher cognitive functioning. A score of 95-115 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.
Change from baseline in resting-state magnetic resonance imaging (MRI) , diffusion tensor imaging (DTI) and structural (T1-weighted) imaging at weeks 1 and 2.
Time frame: Baseline, week 1 and week 2.
Participants will undergo MRI scans prior to beginning HD-tDCS treatment (week 0) and after completing 10 sessions of HD-tDCS treatment (weeks 1) and after completing 20 sessions of HD-tDCS treatment (weeks 2). This allows for a comprehensive examination of changes from baseline in functional activity, DTI and structural changes in the brain at weeks 1 and 2.
24 secondary outcomes
Change from baseline in the Clinical Global Impression-Severity scale (CGI-S) at week 1 and week 2.
Time frame: Baseline, week 1 and week 2.
Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) at week 1 and week 2.
Time frame: Baseline, week 1 and week 2.
Change from baseline in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9; range: 0-27) at baseline, week 1 and week 2.
Time frame: Baseline, week 1 and week 2.
Change from baseline in anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7, range: 0-21) at baseline, week 1 and week 2.
Time frame: Baseline, week 1 and week 2.
Change from baseline in insomnia symptoms assessed by the Insomnia Severity Index (ISI; range: 0-28) at baseline, week 1 and week 2.
Time frame: Baseline, week 1 and week 2.
Change from baseline in suicidal ideation assessed by the Beck Scale for Suicide (BSS-14; range: 0-38) at baseline, week 1 and week 2.
Time frame: Baseline, week 1 and week 2.
Change from baseline in perceived stress assessed by the Perceived Stress Scale-14 (PSS-14; range: 0-56) at baseline, week 1 and week 2.
Time frame: Baseline, week 1 and week 2.
Change from baseline in neurocognitive function using Wsiconsin card sorting test (WCST) at week 2.
Time frame: Baseline and week 2.
Change from baseline in neurocognitive function using Verbal Emotion Perception Test (VEPT) at week 2.
Time frame: Baseline and week 2.
Change from baseline in neurocognitive function using Facial Emotion Perception Test (FEPT) at week 2.
Time frame: Baseline and week 2.
Change from baseline in acoustic features.
Time frame: Baseline, week 1 and week 2.
Change from baseline in manic symptoms assessed by the Young Manic Rating Scale(YMRS) at baseline, week 1 and week 2. scales.
Time frame: Baseline, week 1 and week 2.
Changes from metabolites in peripheral blood.
Time frame: Baseline, week 1 and week 2.
Changes from protein samples in peripheral blood.
Time frame: Baseline, week 1 and week 2.
Changes from methylation in peripheral blood.
Time frame: Baseline, week 1 and week 2.
Electroencephalogram - delta waves (0.5-4 Hz)
Time frame: Baseline
Electroencephalogram - theta waves (4-8 Hz)
Time frame: Baseline
Electroencephalogram - alpha waves (8-13 Hz)
Time frame: Baseline
Electroencephalogram - Beta Waves (13-30 Hz)
Time frame: Baseline
Electroencephalogram- gamma waves (above 30 Hz)
Time frame: Baseline
Change from baseline in psychotic symptoms assessed by the Brief Psychiatric Rating Scale (BPRS) at baseline, week 1 and week 2. scales.
Time frame: Baseline, week 1 and week 2.
Change from baseline in anxious symptoms assessed by the Hamilton anxiely scale (HAMA) at baseline, week 1 and week 2. scales.
Time frame: Baseline, week 1 and week 2.
Change from baseline in anhedonia symptoms assessed by the Snaith-Hamilton Pleasure Scale(SHAPS) at baseline, week 1 and week 2.
Time frame: Baseline, week 1 and week 2.
Change from baseline in anhedonia symptoms assessed by the Temporal Experience of Pleasure Scale (TEPS) at baseline, week 1 and week 2.
Time frame: Baseline, week 1 and week 2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Episode
Active, not recruiting
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Depression, MDD
RecruitingPhase 3
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Wang study chair
Affiliated Nanjing Brain Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Definition Transcranial Direct Current Stimulation (HD-tDCS) and Antipsychotics, mood stabilizers, etc. in people with Major Depressive Episode, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongguo Zhang (+8615189204675, zhangzhongguo1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in depressive symptoms assessed by Hamilton depression rating scale 17 items (HAMD-17) at week 1 and week 2. (time frame: Baseline, week 1 and week 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.