Depressive DisorderNCT06061653
Augmentation of Interpersonal Psychotherapy With High-Definition Transcranial Direct Current Stimulation for Adolescent Depression
A study testing IPT plus HD-tDCS in people with Depressive Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Depression is among the most prevalent psychiatric disorders, with an upward trend in its manifestation in younger individuals. In contrast to adult depression, adolescent depression often presents with longer attack durations, higher recurrence rates, chronicity, and elevated disability rates. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- IPT plus HD-tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 2025
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Sign a written informed consent form, willing to participate in the study and accept treatment (patients under 18 years of age need to obtain the consent of their parents or legal guardians);
- Age between 12 and 18 years;
- Right-handed;
- Han ethnicity;
- Meet the DSM-5 diagnostic criteria for depression;
- HAMD-24≥20;
- Understand written language and able to complete questionnaires;
- First-episode depression patients who have never received any treatment or relapse depression patients, have not taken any psychotropic drugs in the past 2 weeks, have not received systematic psychological or physical therapy.
Who cannot join
- Exclusion criteria for tDCS: (1) Patients with metal implants in the body; those with metal implants such as titanium or magnetic devices (including aneurysm clips); (2) Patients with implanted devices such as cardiac pacemakers, deep brain stimulators (DBS); (3) Patients with intracranial hypertension, skull defects, or tumors; (4) Patients with unstable vital signs such as severe cardiac or somatic diseases; (5) Patients in the acute phase of cerebrovascular diseases; (6) Patients with adverse reactions to electrical stimulation; (7) Patients with pain sensitivity, injury, or inflammation in the stimulation area.
- Exclusion criteria for MRI;
- Patients with severe neurological, cardiac, liver, kidney, endocrine, and blood system diseases, or any other condition that may interfere with the study evaluation;
- Patients with organic mental disorders and mental retardation;
- Patients with alcohol or drug dependence;
- Patients with a high risk of suicide.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
Huang Manli, 13957162975, huangmanli@zju.edu.cn
About this study
Official title: Effects of Augmentation of Interpersonal Psychotherapy With High-Definition Transcranial Direct Current Stimulation for Adolescent Depression: A Randomized Clinical Trial
Depression is among the most prevalent psychiatric disorders, with an upward trend in its manifestation in younger individuals. In contrast to adult depression, adolescent depression often presents with longer attack durations, higher recurrence rates, chronicity, and elevated disability rates. At present, treatment options for adolescent depression encompass pharmacological, physical, and psychological therapies. However, current evidence suggests that no antidepressant medication is entirely safe for youths, with only fluoxetine and escitalopram being FDA-approved for treating adolescent depression.
Given the weight of interpersonal stressors faced by teenagers, the NICE guidelines recommend interpersonal therapy(IPT) as a first-line treatment. A 2020 meta-analysis in the Journal of the American Academy of Child and Adolescent Psychiatry reported that interpersonal therapy exhibited significantly greater improvements in depression symptoms than cognitive behavioral therapy(CBT), although psychotherapeutic effects were modest, achieving a remission rate of 60%. These results underscore the need for further research to enhance interpersonal therapy's effectiveness in treating adolescent depression.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS）is a highly secure non-invasive brain stimulation technique that produces sustained effects even after stimulation has discontinued, rendering it particularly valuable for therapeutic interventions. The proposed study aims to augment a single IPT treatment with HD-tDCS stimulation for adolescent depression. By enhancing the excitability of the cerebral cortex, HD-tDCS could potentially enhance IPT's therapeutic efficacy in treating adolescent depression while facilitating further investigation of its underlying neural circuit mechanisms.
- Conditions
- Depressive Disorder
- Being tested
- IPT plus HD-tDCS, IPT plus sham HD-tDCS
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPT plus HD-tDCSCombination product
psychotherapy plus device
IPT plus sham HD-tDCSCombination product
psychotherapy plus sham device
| Study group | Role | What they receive |
|---|---|---|
| IPT plus HD-tDCS | Experimental | Not described Receives: Combination Product: IPT plus HD-tDCS |
| IPT plus sham HD-tDCS | Sham comparator | Not described Receives: Combination Product: IPT plus sham HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-item Hamilton Depression Rating Scale
Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.
Measured: Baseline
24-item Hamilton Depression Rating Scale
Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.
Measured: 1-month
24-item Hamilton Depression Rating Scale
Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.
Measured: 2-month
24-item Hamilton Depression Rating Scale
Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.
Measured: 3-month
Child Depression Rating Scale-Revised
Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.
Measured: Baseline
Child Depression Rating Scale-Revised
Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.
Measured: 1-month
Child Depression Rating Scale-Revised
Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.
Measured: 2-month
Child Depression Rating Scale-Revised
Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.
Measured: 3-month
Secondary outcomes (48)
17-item Hamilton Anxiety Rating Scale
Score<7:No anxiety; Score≥7:Possibly anxious; Score≥14:Definitely anxious; Score≥21:Definitely significantly anxious; Score≥29:Possibly severely anxious.
Measured: Baseline
17-item Hamilton Anxiety Rating Scale
Score<7:No anxiety; Score≥7:Possibly anxious; Score≥14:Definitely anxious; Score≥21:Definitely significantly anxious; Score≥29:Possibly severely anxious.
Measured: 1-month
17-item Hamilton Anxiety Rating Scale
Score<7:No anxiety; Score≥7:Possibly anxious; Score≥14:Definitely anxious; Score≥21:Definitely significantly anxious; Score≥29:Possibly severely anxious.
Measured: 2-month
17-item Hamilton Anxiety Rating Scale
Score<7:No anxiety; Score≥7:Possibly anxious; Score≥14:Definitely anxious; Score≥21:Definitely significantly anxious; Score≥29:Possibly severely anxious.
Measured: 3-month
Beck Scale for Suicide Ideation
Assessment of suicidal ideation. The test taker first completes the initial five questions. If the responses to both the fourth and fifth items are "no," it is considered that there is no suicidal ideation, and the questionnaire concludes. Suicidal risk is evaluated based on items six to nineteen of the scale, which assess the likelihood of actual suicidal behavior among individuals with suicidal ideation. The calculation formula for the total score is [(sum of scores for items six to nineteen) - 9) / 33] * 100, resulting in a score ranging from 0 to 100. A higher score indicates a greater risk of suicide.
Measured: Baseline
Beck Scale for Suicide Ideation
Assessment of suicidal ideation. The test taker first completes the initial five questions. If the responses to both the fourth and fifth items are "no," it is considered that there is no suicidal ideation, and the questionnaire concludes. Suicidal risk is evaluated based on items six to nineteen of the scale, which assess the likelihood of actual suicidal behavior among individuals with suicidal ideation. The calculation formula for the total score is [(sum of scores for items six to nineteen) - 9) / 33] * 100, resulting in a score ranging from 0 to 100. A higher score indicates a greater risk of suicide.
Measured: 1-month
Beck Scale for Suicide Ideation
Assessment of suicidal ideation. The test taker first completes the initial five questions. If the responses to both the fourth and fifth items are "no," it is considered that there is no suicidal ideation, and the questionnaire concludes. Suicidal risk is evaluated based on items six to nineteen of the scale, which assess the likelihood of actual suicidal behavior among individuals with suicidal ideation. The calculation formula for the total score is [(sum of scores for items six to nineteen) - 9) / 33] * 100, resulting in a score ranging from 0 to 100. A higher score indicates a greater risk of suicide.
Measured: 2-month
Beck Scale for Suicide Ideation
Assessment of suicidal ideation. The test taker first completes the initial five questions. If the responses to both the fourth and fifth items are "no," it is considered that there is no suicidal ideation, and the questionnaire concludes. Suicidal risk is evaluated based on items six to nineteen of the scale, which assess the likelihood of actual suicidal behavior among individuals with suicidal ideation. The calculation formula for the total score is [(sum of scores for items six to nineteen) - 9) / 33] * 100, resulting in a score ranging from 0 to 100. A higher score indicates a greater risk of suicide.
Measured: 3-month
the Chinese version of the Snaith-Hamilton Pleasure Scale
A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score. The higher the score The higher the score, the more severe the pleasure deficit
Measured: Baseline
the Chinese version of the Snaith-Hamilton Pleasure Scale
A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score. The higher the score The higher the score, the more severe the pleasure deficit
Measured: 1-month
the Chinese version of the Snaith-Hamilton Pleasure Scale
A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score. The higher the score The higher the score, the more severe the pleasure deficit
Measured: 2-month
the Chinese version of the Snaith-Hamilton Pleasure Scale
A total of 14 items, each with a score of 1 to 4, will be used to calculate the total score. The higher the score The higher the score, the more severe the pleasure deficit
Measured: 3-month
Interpersonal Relationship Scale
A score of 0-8 indicates that interpersonal relationship is good, a score of 9-14 indicates that there is a certain degree of interpersonal relationship distress, and a score of 15-28 indicates that interpersonal relationship distress is more serious, that is, the lower the score of the comprehensive diagnostic scale of interpersonal relationship, the better the interpersonal relationship.
Measured: Baseline
Interpersonal Relationship Scale
A score of 0-8 indicates that interpersonal relationship is good, a score of 9-14 indicates that there is a certain degree of interpersonal relationship distress, and a score of 15-28 indicates that interpersonal relationship distress is more serious, that is, the lower the score of the comprehensive diagnostic scale of interpersonal relationship, the better the interpersonal relationship.
Measured: 1-month
Interpersonal Relationship Scale
A score of 0-8 indicates that interpersonal relationship is good, a score of 9-14 indicates that there is a certain degree of interpersonal relationship distress, and a score of 15-28 indicates that interpersonal relationship distress is more serious, that is, the lower the score of the comprehensive diagnostic scale of interpersonal relationship, the better the interpersonal relationship.
Measured: 2-month
Interpersonal Relationship Scale
A score of 0-8 indicates that interpersonal relationship is good, a score of 9-14 indicates that there is a certain degree of interpersonal relationship distress, and a score of 15-28 indicates that interpersonal relationship distress is more serious, that is, the lower the score of the comprehensive diagnostic scale of interpersonal relationship, the better the interpersonal relationship.
Measured: 3-month
Emotion Regulation Questionnaire
A total of 10 items were scored at 7 points. The higher the score, the higher the frequency of using emotion regulation strategies.
Measured: Baseline
Emotion Regulation Questionnaire
A total of 10 items were scored at 7 points. The higher the score, the higher the frequency of using emotion regulation strategies.
Measured: 1-month
Emotion Regulation Questionnaire
A total of 10 items were scored at 7 points. The higher the score, the higher the frequency of using emotion regulation strategies.
Measured: 2-month
Emotion Regulation Questionnaire
A total of 10 items were scored at 7 points. The higher the score, the higher the frequency of using emotion regulation strategies.
Measured: 3-month
Toronto Alexithymia Scale-20
It consists of 3 factors, difficulty identifying feelings (DIF), difficulty describing feelings (DDF), and externally oriented thinking (EOT), which are called F1, F2, and F3 factors, containing 20 items, each scored within a 5-point scale (1: completely disagree to 5: completely agree), 20-100 points, the higher the score, the more pronounced the dysfunction in describing feelings.
Measured: Baseline
Toronto Alexithymia Scale-20
It consists of 3 factors, difficulty identifying feelings (DIF), difficulty describing feelings (DDF), and externally oriented thinking (EOT), which are called F1, F2, and F3 factors, containing 20 items, each scored within a 5-point scale (1: completely disagree to 5: completely agree), 20-100 points, the higher the score, the more pronounced the dysfunction in describing feelings.
Measured: 1-month
Toronto Alexithymia Scale-20
It consists of 3 factors, difficulty identifying feelings (DIF), difficulty describing feelings (DDF), and externally oriented thinking (EOT), which are called F1, F2, and F3 factors, containing 20 items, each scored within a 5-point scale (1: completely disagree to 5: completely agree), 20-100 points, the higher the score, the more pronounced the dysfunction in describing feelings.
Measured: 2-month
Toronto Alexithymia Scale-20
It consists of 3 factors, difficulty identifying feelings (DIF), difficulty describing feelings (DDF), and externally oriented thinking (EOT), which are called F1, F2, and F3 factors, containing 20 items, each scored within a 5-point scale (1: completely disagree to 5: completely agree), 20-100 points, the higher the score, the more pronounced the dysfunction in describing feelings.
Measured: 3-month
The Reflective Function Questionnaire for Youths
Assesses the degree of agreement or disagreement with narratives about reflective functioning, with higher scores representing higher levels of reflective functioning.
Measured: Baseline
The Reflective Function Questionnaire for Youths
Assesses the degree of agreement or disagreement with narratives about reflective functioning, with higher scores representing higher levels of reflective functioning.
Measured: 1-month
The Reflective Function Questionnaire for Youths
Assesses the degree of agreement or disagreement with narratives about reflective functioning, with higher scores representing higher levels of reflective functioning.
Measured: 2-month
The Reflective Function Questionnaire for Youths
Assesses the degree of agreement or disagreement with narratives about reflective functioning, with higher scores representing higher levels of reflective functioning.
Measured: 3-month
Comfort Rating Questionnaire
Evaluating adverse reactions of tdcs.
Measured: Baseline
Comfort Rating Questionnaire
Evaluating adverse reactions of tdcs.
Measured: 1-month
Comfort Rating Questionnaire
Evaluating adverse reactions of tdcs.
Measured: 2-month
Comfort Rating Questionnaire
Evaluating adverse reactions of tdcs.
Measured: 3-month
IL-6 level
Detection of serum IL-6 levels using flow cytometry. The normal value is 0-5.30 pg/ml. There is a goodcorrelation between depression and elevated serum IL-6 levels.
Measured: Baseline
IL-6 level
Detection of serum IL-6 levels using flow cytometry. The normal value is 0-5.30 pg/ml. There is a goodcorrelation between depression and elevated serum IL-6 levels.
Measured: 2-month
MRI data
Reflecting brain structure and function
Measured: Baseline
MRI data
Reflecting brain structure and function
Measured: 2-month
EEG data
Reflecting brain function. It will be used for analysing Left-right asymmetry of forehead Alpha wave energy，mapping the brainnetworks.
Measured: Baseline
EEG data
Reflecting brain function. It will be used for analysing Left-right asymmetry of forehead Alpha wave energy，mapping the brainnetworks.
Measured: 2-month
TMS-evoked potentials(TEPs)
Reflecting cortical excitability. N15, P30, N45, P55, N100, P180 and N280 components were evoked during single-pulse TMS stimulation of motor cortex (M1). Early components of TEPs (N15-P30) reflect cortical excitatory activity, while other components (N45-N100) are associated with cortical inhibitory activity.
Measured: Baseline
TMS-evoked potentials(TEPs)
Reflecting cortical excitability. N15, P30, N45, P55, N100, P180 and N280 components were evoked during single-pulse TMS stimulation of motor cortex (M1). Early components of TEPs (N15-P30) reflect cortical excitatory activity, while other components (N45-N100) are associated with cortical inhibitory activity.
Measured: 2-month
Thinc-integrated Tools(THINC-it)
THINC-it（https://progress.im/en/）is the first tool to assess cognitive functioning in MDD using both subjective and objective tests and is available as a free download for use on tablets, smartphones or computers. The tool's four objective test sections use recognized cognitive paradigms to assess subjects' performance in the key cognitive domains of attention, working memory, and executive function. The Choice Reaction Time (CRT) focuses on attention and executive function, the 1-Back Memory Task (1-Back) examines memory, attention/concentration, and executive function, the Digit Symbol Substitution Test (DSST) examines processing speed, attention, and executive function, and the Test of Connectivity B (TMT-B) assesses executive function. The 5-item Cognitive Impairment Questionnaire (PDQ⁃5⁃D) is the subjective component of the instrument and can be used to assess patients' performance in attention/concentration, planning/organization, retrospection, and prospective memory.
Measured: Baseline
Thinc-integrated Tools(THINC-it)
THINC-it（https://progress.im/en/）is the first tool to assess cognitive functioning in MDD using both subjective and objective tests and is available as a free download for use on tablets, smartphones or computers. The tool's four objective test sections use recognized cognitive paradigms to assess subjects' performance in the key cognitive domains of attention, working memory, and executive function. The Choice Reaction Time (CRT) focuses on attention and executive function, the 1-Back Memory Task (1-Back) examines memory, attention/concentration, and executive function, the Digit Symbol Substitution Test (DSST) examines processing speed, attention, and executive function, and the Test of Connectivity B (TMT-B) assesses executive function. The 5-item Cognitive Impairment Questionnaire (PDQ⁃5⁃D) is the subjective component of the instrument and can be used to assess patients' performance in attention/concentration, planning/organization, retrospection, and prospective memory.
Measured: 2-month
Perceptual judgment test
Assess subjects' perception of interpersonal information.
Measured: Baseline
Perceptual judgment test
Assess subjects' perception of interpersonal information.
Measured: 2-month
Distance memory test
Assessment of Working memory.
Measured: Baseline
Distance memory test
Assessment of Working memory.
Measured: 2-month
ERP experiment
The participants are instructed to watch the animations，while EEG data is recorded. Event-related Mu-wave will be used for evaluating social interaction ability.
Measured: Baseline
ERP experiment
The participants are instructed to watch the animations，while EEG data is recorded. Event-related Mu-wave will be used for evaluating social interaction ability.
Measured: 2-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061653
- Sponsor's protocol ID
- IIT2023496
- Status last verified
- May 2023
- First submitted
- 8 Aug 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Augmentation of Interpersonal Psychotherapy With High-Definition Transcranial Direct Current Stimulation for Adolescent Depression: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06061653
- Acronym / sponsor ID
- IIT2023496
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Sep 2023 (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.
Depression is among the most prevalent psychiatric disorders, with an upward trend in its manifestation in younger individuals. In contrast to adult depression, adolescent depression often presents with longer attack durations, higher recurrence rates, chronicity, and elevated disability rates. At present, treatment options for adolescent depression encompass pharmacological, physical, and psychological therapies. However, current evidence suggests that no antidepressant medication is entirely safe for youths, with only fluoxetine and escitalopram being FDA-approved for treating adolescent depression.
Given the weight of interpersonal stressors faced by teenagers, the NICE guidelines recommend interpersonal therapy(IPT) as a first-line treatment. A 2020 meta-analysis in the Journal of the American Academy of Child and Adolescent Psychiatry reported that interpersonal therapy exhibited significantly greater improvements in depression symptoms than cognitive behavioral therapy(CBT), although psychotherapeutic effects were modest, achieving a remission rate of 60%. These results underscore the need for further research to enhance interpersonal therapy's effectiveness in treating adolescent depression.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS）is a highly secure non-invasive brain stimulation technique that produces sustained effects even after stimulation has discontinued, rendering it particularly valuable for therapeutic interventions. The proposed study aims to augment a single IPT treatment with HD-tDCS stimulation for adolescent depression. By enhancing the excitability of the cerebral cortex, HD-tDCS could potentially enhance IPT's therapeutic efficacy in treating adolescent depression while facilitating further investigation of its underlying neural circuit mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPT plus HD-tDCS | Experimental | Combination Product: IPT plus HD-tDCS |
| IPT plus sham HD-tDCS | Sham comparator | Combination Product: IPT plus sham HD-tDCS |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Sign a written informed consent form, willing to participate in the study and accept treatment (patients under 18 years of age need to obtain the consent of their parents or legal guardians);
- Age between 12 and 18 years;
- Right-handed;
- Han ethnicity;
- Meet the DSM-5 diagnostic criteria for depression;
Key exclusion criteria (6 listed)
- Exclusion criteria for tDCS: (1) Patients with metal implants in the body; those with metal implants such as titanium or magnetic devices (including aneurysm clips); (2) Patients with implanted devices such as cardiac pacemakers, deep brain stimulators (DBS); (3) Patients with intracranial hypertension, skull defects, or tumors; (4) Patients with unstable vital signs such as severe cardiac or somatic diseases; (5) Patients in the acute phase of cerebrovascular diseases; (6) Patients with adverse reactions to electrical stimulation; (7) Patients with pain sensitivity, injury, or inflammation in the stimulation area.
- Exclusion criteria for MRI;
- Patients with severe neurological, cardiac, liver, kidney, endocrine, and blood system diseases, or any other condition that may interfere with the study evaluation;
- Patients with organic mental disorders and mental retardation;
- Patients with alcohol or drug dependence;
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 |
|---|---|---|
| IPT plus HD-tDCSpsychotherapy plus device | Combination product | IPT plus HD-tDCS |
| IPT plus sham HD-tDCSpsychotherapy plus sham device | Combination product | IPT plus sham HD-tDCS |
Primary outcome
24-item Hamilton Depression Rating Scale
Time frame: Baseline
Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.
24-item Hamilton Depression Rating Scale
Time frame: 1-month
Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.
24-item Hamilton Depression Rating Scale
Time frame: 2-month
Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.
24-item Hamilton Depression Rating Scale
Time frame: 3-month
Assessment of depressive symptoms. Score<8: normal; >20: mild or moderate depression; >35: severe depression.
Child Depression Rating Scale-Revised
Time frame: Baseline
Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.
Child Depression Rating Scale-Revised
Time frame: 1-month
Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.
Child Depression Rating Scale-Revised
Time frame: 2-month
Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.
Child Depression Rating Scale-Revised
Time frame: 3-month
Assessment of depressive symptoms. Score<40: normal; 40~60: mild or moderate depression; >60: severe depression.
48 secondary outcomes
17-item Hamilton Anxiety Rating Scale
Time frame: Baseline
17-item Hamilton Anxiety Rating Scale
Time frame: 1-month
17-item Hamilton Anxiety Rating Scale
Time frame: 2-month
17-item Hamilton Anxiety Rating Scale
Time frame: 3-month
Beck Scale for Suicide Ideation
Time frame: Baseline
Beck Scale for Suicide Ideation
Time frame: 1-month
Beck Scale for Suicide Ideation
Time frame: 2-month
Beck Scale for Suicide Ideation
Time frame: 3-month
the Chinese version of the Snaith-Hamilton Pleasure Scale
Time frame: Baseline
the Chinese version of the Snaith-Hamilton Pleasure Scale
Time frame: 1-month
the Chinese version of the Snaith-Hamilton Pleasure Scale
Time frame: 2-month
the Chinese version of the Snaith-Hamilton Pleasure Scale
Time frame: 3-month
Interpersonal Relationship Scale
Time frame: Baseline
Interpersonal Relationship Scale
Time frame: 1-month
Interpersonal Relationship Scale
Time frame: 2-month
Interpersonal Relationship Scale
Time frame: 3-month
Emotion Regulation Questionnaire
Time frame: Baseline
Emotion Regulation Questionnaire
Time frame: 1-month
Emotion Regulation Questionnaire
Time frame: 2-month
Emotion Regulation Questionnaire
Time frame: 3-month
Toronto Alexithymia Scale-20
Time frame: Baseline
Toronto Alexithymia Scale-20
Time frame: 1-month
Toronto Alexithymia Scale-20
Time frame: 2-month
Toronto Alexithymia Scale-20
Time frame: 3-month
The Reflective Function Questionnaire for Youths
Time frame: Baseline
The Reflective Function Questionnaire for Youths
Time frame: 1-month
The Reflective Function Questionnaire for Youths
Time frame: 2-month
The Reflective Function Questionnaire for Youths
Time frame: 3-month
Comfort Rating Questionnaire
Time frame: Baseline
Comfort Rating Questionnaire
Time frame: 1-month
Comfort Rating Questionnaire
Time frame: 2-month
Comfort Rating Questionnaire
Time frame: 3-month
IL-6 level
Time frame: Baseline
IL-6 level
Time frame: 2-month
MRI data
Time frame: Baseline
MRI data
Time frame: 2-month
EEG data
Time frame: Baseline
EEG data
Time frame: 2-month
TMS-evoked potentials(TEPs)
Time frame: Baseline
TMS-evoked potentials(TEPs)
Time frame: 2-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPT plus HD-tDCS in people with Depressive Disorder, run by First Affiliated Hospital of Zhejiang University 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 8 inclusion and 6 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 31 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. Some participants in this study may receive a placebo. 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 Manli Huang, M.D (13957162975 ext. 86, huangmanli@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-item Hamilton Depression Rating Scale (time frame: Baseline). The study lists 8 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 31 Oct 2023.