Back to resultsEfficacy of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Major Depressive Disorder
Primary Purpose
Major Depressive Disorders
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)-active
Transcranial Direct Current Stimulation (tDCS)-sham
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorders focused on measuring drug-naïve Major depressive disorder, transcranial Direct Current Stimulation (tDCS)
Eligibility Criteria
Inclusion Criteria:
- a current episode of MDD diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- age between 18 and 50 years
- a total score of HAMD-17 ≥ 17
- take antidepressants less than 3 days
- Patients are compliant with treatment according to the judgement of the treating clinician.
Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised.
Exclusion Criteria:
- A history of manic episode
- Use of mood stabilizer
- History of substance abuse or dependence
- Severe somatic diseases that might interfere with regular antidepressant treatment including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma.
- Use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial
- Use of immunosuppressive medication such as oral steroid hormones Women in pregnancy or lactation period
Sites / Locations
- Tianjin Anding HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
tDCS group
Sham group
Arm Description
participants receive 20 min sessions of 2 mA direct current delivered over the dorsolateral prefrontal cortex, 5 days per week, for 4 weeks combine a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitors(SNRI)
Participants receive sham stimulation that administered similarly, but with current turned off after 30s combine a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitors(SNRI)
Outcomes
Primary Outcome Measures
The change of scores in Hamilton Depression Rating Scale (HAMD)-17 from baseline to week 4.
The main objective is to explore whether tDCS add on SSRI or SNRI will improve the MDD symptoms after 4 weeks of treatment, and investigators assess the scale at baseline and week 1, 2, 3, 4. Hamilton Depression Rating Scale (HAMD)-17 items was used to evaluate the severity of symptoms of depression. A total score of more than 24 may indicate severe depressive symptoms; A score above 17 may be mild to moderate depressive; If the score is less than 7, the patient has no symptoms of depression. The higher the total score of the scale, the more severe the depressive symptoms.
Secondary Outcome Measures
The change of scores in Hamilton Anxiety Rating Scale (HAMA) from baseline to Week 4.
The aim is to explore whether tDCS add on SSRI or SNRI will alleviate the severity of anxious symptoms as measured with HAMA after 4 weeks of treatment, and investigators assess the scale at baseline and week 1, 2, 3, 4. Hamilton Anxiety Rating Scale (HAMA) was used to evaluate the severity of anxiety symptoms and the effects of intervention in patients with anxiety and depressive disorders. The total score ≥ 29 may be severe anxiety; ≥ 21, there may be obvious anxiety; ≥ 14, there may be anxiety; more than 7, there may be anxiety; if less than 7, there will be no anxiety symptoms.
The change of scores in Pittsburgh Sleep Quality Index (PSQI) from basline to week 8.
The aim is to investigate whether active-stimuli in addition to regular treatment with an antidepressant will improve the sleep quality as measured with Pittsburgh Sleep Quality Index (PSQI) after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline and week 4,8. PSQI was used to evaluate the sleep quality of the subjects in the last month. The total score of PSQI ranged from 0 to 21. The higher the score, the worse the sleep quality.
The change of scores in quality of life (QOL) from baseline to week 8.
The aim is to investigate whether active-stimuli in addition to regular treatment with an antidepressant will improve the quality of life as measured with quality of life (QOL) after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline and week 4,8. The QOL scale evaluates the physical health, mental health, social relations and other aspects of the participants. The higher the score is, the better the quality of life is.
The change of sores in suicidal risk assessment scale from baseline to week 8
The aim is to investigate whether active-stimuli in addition to regular treatment with an antidepressant will reduce the risk suicide as measured with the suicidal risk assessment scale after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline and week 4,8. The higher the score of the suicidal risk assessment scale, the higher the risk of suicide.
The change of scores in Repeatable Battery for the Assessment of neuropsychological Status (Rebans).
The aim is to observe whether active-stimuli in addition to regular treatment with an antidepressant will improve the cognitive function as measured with Repeatable Battery for the Assessment of Neuropsychological Status (Rebans) after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline and week 4,8. The higher the score of the scale, the cognitive function is better.
The changes of levels of biomarkers in peripheral blood from baseline to week 4
The aim is to investigate the change of cortisol level of saliva and intestinal flora as active stimuli in addition to regular treatment with an antidepressant after 4 weeks of treatment compared to sham stimuli, and investigators collect the specimens at baseline and week 4.
Saliva collection tube to collect saliva, collect naturally discharged saliva in a clean test tube (at least 2ml). Saliva was centrifuged under 1500rpm for 15 minutes and the filtrate was cryopreserved at-80 °C. the saliva was analyzed by ELISA kit.
Fecal collection: a) intercept the middle part of the sample with a sterile toothpick or fecal sampler (the surface of feces contains exfoliated cells of intestinal mucosa; the outside is easy to be contaminated, and some bacterial DNA begins to degrade after contact with air), take about the size of peanuts and put them into aseptic 2.0mL centrifuge tubes, 3-5 tubes for each sample are taken for backup，and then put into-80 °C cryopreservation after sub-packaging.
Adverse events from baseline to week 4
The aim is to evaluate the adverse effects during the treatment.
Full Information
NCT ID
NCT04497493
First Posted
July 22, 2020
Last Updated
October 17, 2021
Sponsor
Tianjin Anding Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04497493
Brief Title
Efficacy of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Major Depressive Disorder
Official Title
Efficacy of Transcranial Direct Current Stimulation (tDCS) of Dorsolateral-prefrontal Cortex as an Add-on Treatment for Drug-naïve Major Depressive Disorder: A Randomized, Double-blind, Sham-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Anding Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to assess the efficacy of Transcranial Direct Current Stimulation (tDCS) as an Add-on Treatment for the drug-naïve Major depressive disorder. Meanwhile, evaluate the effect of tDCS on cognitive function of drug-naïve MDD patients. Furthermore, the investigators will examine the changes in cortisol, gut microbiome and some biomarkers. The hypothesis of this study is that tDCS alleviate the depressive symptoms and improve the cognitive function of drug-naïve Major depressive disorder patients with regulating inflammatory response.
Detailed Description
This is a randomized, double-blind, sham-controlled study using transcranial Direct Current Stimulation (tDCS) for 4-week treatment. After the intervention of tDCS, there is a follow up visit at week 8 in order to understand the long-term effects of tDCS. Participants were randomly assigned 1:1 to tDCS group or sham-control group. Active tDCS comprised 20 min sessions of 2 mA direct current delivered over the dorsolateral prefrontal cortex, 5 days per week, for 4 weeks. Sham was administered similarly, but with current turned off after 30s. Apart from studying the effects of tDCS on severity of depression and cognitive function, the secondary outcomes are to examine biomarkers related to inflammatory activity. Scale assessments are performed before the initiation of treatment, week 1, week 2, week 3, week 4 and week8. Collection of blood, excrement and saliva takes place at three time points, at the baseline, week 4 and week 8.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorders
Keywords
drug-naïve Major depressive disorder, transcranial Direct Current Stimulation (tDCS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS group
Arm Type
Experimental
Arm Description
participants receive 20 min sessions of 2 mA direct current delivered over the dorsolateral prefrontal cortex, 5 days per week, for 4 weeks combine a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitors(SNRI)
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Participants receive sham stimulation that administered similarly, but with current turned off after 30s combine a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitors(SNRI)
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)-active
Other Intervention Name(s)
active
Intervention Description
Transcranial direct current stimulation (TDC) is a non-invasive neuromodulation technique of the brain with a DC microelectrical stimulator, a cathode electrode and an anode electrode, and a control software to set the output of the stimulation type，participants receive 20 min sessions of 2 mA direct current delivered over the dorsolateral prefrontal cortex, 5 days per week, for 4 weeks
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)-sham
Other Intervention Name(s)
sham
Intervention Description
Transcranial direct current stimulation (TDC) is a non-invasive neuromodulation technique of the brain with a DC microelectrical stimulator, a cathode electrode and an anode electrode, and a control software to set the output of the stimulation type. Participants receive sham stimulation over the dorsolateral prefrontal cortex, with current turned off after 30 second. The session last 20 min 5 days per week, for 4 weeks
Primary Outcome Measure Information:
Title
The change of scores in Hamilton Depression Rating Scale (HAMD)-17 from baseline to week 4.
Description
The main objective is to explore whether tDCS add on SSRI or SNRI will improve the MDD symptoms after 4 weeks of treatment, and investigators assess the scale at baseline and week 1, 2, 3, 4. Hamilton Depression Rating Scale (HAMD)-17 items was used to evaluate the severity of symptoms of depression. A total score of more than 24 may indicate severe depressive symptoms; A score above 17 may be mild to moderate depressive; If the score is less than 7, the patient has no symptoms of depression. The higher the total score of the scale, the more severe the depressive symptoms.
Time Frame
baseline, Week 1, week 2, week 3, week 4
Secondary Outcome Measure Information:
Title
The change of scores in Hamilton Anxiety Rating Scale (HAMA) from baseline to Week 4.
Description
The aim is to explore whether tDCS add on SSRI or SNRI will alleviate the severity of anxious symptoms as measured with HAMA after 4 weeks of treatment, and investigators assess the scale at baseline and week 1, 2, 3, 4. Hamilton Anxiety Rating Scale (HAMA) was used to evaluate the severity of anxiety symptoms and the effects of intervention in patients with anxiety and depressive disorders. The total score ≥ 29 may be severe anxiety; ≥ 21, there may be obvious anxiety; ≥ 14, there may be anxiety; more than 7, there may be anxiety; if less than 7, there will be no anxiety symptoms.
Time Frame
baseline, Week 1, week 2, week 3, week 4
Title
The change of scores in Pittsburgh Sleep Quality Index (PSQI) from basline to week 8.
Description
The aim is to investigate whether active-stimuli in addition to regular treatment with an antidepressant will improve the sleep quality as measured with Pittsburgh Sleep Quality Index (PSQI) after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline and week 4,8. PSQI was used to evaluate the sleep quality of the subjects in the last month. The total score of PSQI ranged from 0 to 21. The higher the score, the worse the sleep quality.
Time Frame
baseline, Week 4, week8
Title
The change of scores in quality of life (QOL) from baseline to week 8.
Description
The aim is to investigate whether active-stimuli in addition to regular treatment with an antidepressant will improve the quality of life as measured with quality of life (QOL) after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline and week 4,8. The QOL scale evaluates the physical health, mental health, social relations and other aspects of the participants. The higher the score is, the better the quality of life is.
Time Frame
baseline, Week 4, week 8
Title
The change of sores in suicidal risk assessment scale from baseline to week 8
Description
The aim is to investigate whether active-stimuli in addition to regular treatment with an antidepressant will reduce the risk suicide as measured with the suicidal risk assessment scale after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline and week 4,8. The higher the score of the suicidal risk assessment scale, the higher the risk of suicide.
Time Frame
baseline, Week 4, week 8
Title
The change of scores in Repeatable Battery for the Assessment of neuropsychological Status (Rebans).
Description
The aim is to observe whether active-stimuli in addition to regular treatment with an antidepressant will improve the cognitive function as measured with Repeatable Battery for the Assessment of Neuropsychological Status (Rebans) after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline and week 4,8. The higher the score of the scale, the cognitive function is better.
Time Frame
baseline, Week 4, week 8
Title
The changes of levels of biomarkers in peripheral blood from baseline to week 4
Description
The aim is to investigate the change of cortisol level of saliva and intestinal flora as active stimuli in addition to regular treatment with an antidepressant after 4 weeks of treatment compared to sham stimuli, and investigators collect the specimens at baseline and week 4.
Saliva collection tube to collect saliva, collect naturally discharged saliva in a clean test tube (at least 2ml). Saliva was centrifuged under 1500rpm for 15 minutes and the filtrate was cryopreserved at-80 °C. the saliva was analyzed by ELISA kit.
Fecal collection: a) intercept the middle part of the sample with a sterile toothpick or fecal sampler (the surface of feces contains exfoliated cells of intestinal mucosa; the outside is easy to be contaminated, and some bacterial DNA begins to degrade after contact with air), take about the size of peanuts and put them into aseptic 2.0mL centrifuge tubes, 3-5 tubes for each sample are taken for backup，and then put into-80 °C cryopreservation after sub-packaging.
Time Frame
baseline, week 4
Title
Adverse events from baseline to week 4
Description
The aim is to evaluate the adverse effects during the treatment.
Time Frame
week 1, week 2, week 3, week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a current episode of MDD diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
age between 18 and 50 years
a total score of HAMD-17 ≥ 17
take antidepressants less than 3 days
Patients are compliant with treatment according to the judgement of the treating clinician.
Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised.
Exclusion Criteria:
A history of manic episode
Use of mood stabilizer
History of substance abuse or dependence
Severe somatic diseases that might interfere with regular antidepressant treatment including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma.
Use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial
Use of immunosuppressive medication such as oral steroid hormones Women in pregnancy or lactation period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Li, Doctor
Phone
022-88188006
Email
tjlijie3827@163.com
Facility Information:
Facility Name
Tianjin Anding Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Li, Doctor
Phone
+86 022 88188006
Email
tjlijie3827@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Major Depressive Disorder
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