Efficacy of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Major Depressive Disorder

NCT ID: NCT04497493

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-22

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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tDCS group

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)

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)-active

Intervention Type DEVICE

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

Sham group

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)

Group Type SHAM_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)-sham

Intervention Type DEVICE

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

Interventions

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Transcranial Direct Current Stimulation (tDCS)-active

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

Transcranial Direct Current Stimulation (tDCS)-sham

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

Intervention Type DEVICE

Other Intervention Names

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active sham

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Anding Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Anding Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jie Li, Doctor

Role: CONTACT

022-88188006

Facility Contacts

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Jie Li, Doctor

Role: primary

+86 022 88188006

Other Identifiers

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tDCS-2020-TJAH

Identifier Type: -

Identifier Source: org_study_id