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

NCT04497493 | Unknown DMC

• 1 other identifier: tDCS-2020-TJAH
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorders

Keywords

drug-naïve Major depressive disorder; transcranial Direct Current Stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, Week 1, week 2, week 3, week 4

Secondary Outcomes (7)

• The change of scores in Hamilton Anxiety Rating Scale (HAMA) from baseline to Week 4.

  baseline, Week 1, week 2, week 3, week 4

• The change of scores in Pittsburgh Sleep Quality Index (PSQI) from basline to week 8.

  baseline, Week 4, week8

• The change of scores in quality of life (QOL) from baseline to week 8.

  baseline, Week 4, week 8

• The change of sores in suicidal risk assessment scale from baseline to week 8

  baseline, Week 4, week 8

• The change of scores in Repeatable Battery for the Assessment of neuropsychological Status (Rebans).

  baseline, Week 4, week 8

Study Arms (2)

tDCS group

EXPERIMENTAL

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)

Device: Transcranial Direct Current Stimulation (tDCS)-active

Sham group

SHAM COMPARATOR

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)

Device: Transcranial Direct Current Stimulation (tDCS)-sham

Interventions

Transcranial Direct Current Stimulation (tDCS)-active 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

Also known as: active

tDCS group

Transcranial Direct Current Stimulation (tDCS)-sham 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

Also known as: sham

Sham group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Jie Li, Doctor

CONTACT

022-88188006; tjlijie3827@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 4, 2020
• Study Start: May 22, 2020
• Primary Completion: October 1, 2022
• Study Completion: March 1, 2023
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

CN (1)