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Adjunctive Duration-doubled tDCS for the Treatment of Depressive Patients With Suicidal Ideation

Primary Purpose

Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ages are from 18 to 50;
  2. Meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for current unipolar MDD, which is assessed by at least one professional psychiatrist;
  3. Han ethnicity;
  4. Right handedness;
  5. With a score≥17 on the HAMD-1713;
  6. With a score≥6 on the BSI14;
  7. Without any pharmacotherapy at baseline or maintaining actual pharmacotherapy for at least 2 weeks before the stimulation initiation and during the total stimulation period.

Exclusion Criteria:

  1. Assessed through applying the Mini-International Neuropsychiatric Interview (MINI)15 by professional psychiatrists that diagnosed any other current or past psychiatric axis-I disorders (except MDD in the patients);
  2. Severe liver and kidney diseases, active endocrine diseases or clinical symptoms. Severe cardiovascular disease, respiratory system disease, haematologic diseases and cancer;
  3. Any clinically significant abnormal laboratory examination that may influence the health of participants;
  4. A history of any aignificant medical illness such as neurological disorders (such as cerebral trauma, seizure disorder, etc);
  5. Known current psychosis as determined by the DSM-5 or a history of a non-mood psychotic disorder;
  6. Current alcohol and drug abuse;
  7. Pregnancy or lactation;
  8. Abnormal scalp such as open wounds;
  9. HAMD-17 item 3 (suicide) score=4;
  10. Receiving modified electroconvulsive therapy (MECT) or repetitive transcranial magnetic stimulation (rTMS) in the past 1 month;
  11. Participation in another clinical trial concurrently or no more than 1 month prior to randomisation.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active tDCS

sham tDCS

Arm Description

tDCS devices (Neuroelectrics, Starstim 8, USA) are used. The anode and cathode electrodes are inserted in saline-soaked sponges with diameter of 3.2cm and then positioned over the left and right dorsolateral prefrontal cortex (DLPFC) using specific headgear. Each session uses a 2mA current and lasts 60 minutes. Ten sessions are daily performed.

The anode and cathode electrodes are inserted in saline-soaked sponges with diameter of 3.2cm and then positioned over the left and right dorsolateral prefrontal cortex (DLPFC) using specific headgear. Each session uses a 2mA current and lasts 60 minutes. Ten sessions are daily performed. For sham, the current rapidly ramp up to 2mA over the first 30s and rapidly ramped down to 0mA over the next 30s automatically to allow participants to feel typical initial sensations of active tDCS.

Outcomes

Primary Outcome Measures

Beck rating scale for suicidal ideation (BSI)
Change from Baseline BSI at week 1 and week 2

Secondary Outcome Measures

Full Information

First Posted
September 14, 2022
Last Updated
September 25, 2022
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05555927
Brief Title
Adjunctive Duration-doubled tDCS for the Treatment of Depressive Patients With Suicidal Ideation
Official Title
Adjunctive Duration-doubled Transcranial Direct Current Stimulation (tDCS) for the Treatment of Depressive Patients With Suicidal Ideation: Study Protocol for a Double-blind, Randomized, Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In this double-blinded, randomized, sham-controlled trial, the investigators aim to determine the acute effectiveness of duration-doubled tDCS on suicidal ideation in patients with MDD. In addition to the their usual treatment, participants will be randomly assigned to receive either 10 weekday sessions of active (2 mA) or sham tDCS as an adjunctive treatment, with the anode over the left DLPFC and the cathode over the right DLPFC. The investigators will regularly assess suicidal ideation, depression severity and functional impact using the BSI, HAMD-17, MADRS, ODQ, YMRS, ASRM, CGI and SDS throughout the trial. The investigators will assess cognitive changes using WCST and SCWT. The investigators will also regularly assess treatment-related side effects using validated scales.
Detailed Description
Backgroud: During the last decade, the problem of suicide has become increasingly common in individuals with depression. Transcranial direct current stimulation (tDCS) is an effective treatment for major depressive disorder (MDD) with 2 milliamperes (mA) for at least thirty minutes per day for two weeks. Aims: To investigate the efficacy of daily duration-doubled performed tDCS as an adjunctive intervention for rapidly improving suicidal ideation and depression in MDD patients with antidepressants. Methods and design: In this double-blind, randomized, sham-controlled study, 76 MDD patients with suicidal ideation will be randomly assigned to either active (n=38) or sham (n=38) tDCS group. The anode and the cathode are placed over the scalp areas corresponding to the left and the right dorsolateral prefrontal cortex (DLPFC), respectively, and the stimulation lasts for 60 minutes. The primary outcome, severity of suicidal ideation, is measured by the Beck Scale for Suicide Ideation (BSI). The 17-item Hamilton Depression Rating Scale (HAMD-17) and Montgomery-Asberg Depression Rating Scale (MADRS) are utilized to assess the severity of depression. The Wisconsin Card Sorting Test (WCST) and Stroop Color-Word Test (SCWT) are adopted to assess executive function. Blood biomarkers are collected at baseline, after the 5th intervention and at the end of 10th intervention to calculate white blood cell (WBC), C-reactive protein (CRP), neutrophils, lymphocytes, monocytes, platelets and MDD related cytokines such as nerve growth factor (NGF), brain-derived (BDNF), glial-cell line derived neurotrophic factor (GDNF), the interleukins (IL), tumor necrosis factor-alpha (TNF-alpha), and its soluble receptors sTNFr1 and sTNFr2. The investigators hypothesis that, in contrast to the sham group, the active tDCS group may show a superiority in BSI, HAMD-17, MADRS score reduction after 5 and 10 sessions. Moreover, the investigators will evaluate associations of the improvement of suicidal ideation with the variation of WBC, CRP, neutrophils, lymphocytes, monocytes, platelets, neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), and platelet-to-lymphocyte ratio (PLR) count. Conclusions: This study suggest that the adjunctive duration-doubled tDCS might be a novel method to rapidly reduce suicidal ideation and improve depressive symptom. And the variation of peripheral markers could be potential biomarkers of suicide risk and severity of MDD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Experimental
Arm Description
tDCS devices (Neuroelectrics, Starstim 8, USA) are used. The anode and cathode electrodes are inserted in saline-soaked sponges with diameter of 3.2cm and then positioned over the left and right dorsolateral prefrontal cortex (DLPFC) using specific headgear. Each session uses a 2mA current and lasts 60 minutes. Ten sessions are daily performed.
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
The anode and cathode electrodes are inserted in saline-soaked sponges with diameter of 3.2cm and then positioned over the left and right dorsolateral prefrontal cortex (DLPFC) using specific headgear. Each session uses a 2mA current and lasts 60 minutes. Ten sessions are daily performed. For sham, the current rapidly ramp up to 2mA over the first 30s and rapidly ramped down to 0mA over the next 30s automatically to allow participants to feel typical initial sensations of active tDCS.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Intervention Description
Transcranial direct current stimulation is an non-invasive brain stimulation that is proposed as a possible interventional tool for major depressive disorder. tDCS device that this study used is from Neuroelectrics, Starstim 8, USA.
Primary Outcome Measure Information:
Title
Beck rating scale for suicidal ideation (BSI)
Description
Change from Baseline BSI at week 1 and week 2
Time Frame
At week 1 and week 2

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: Ages are from 18 to 50; Meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for current unipolar MDD, which is assessed by at least one professional psychiatrist; Han ethnicity; Right handedness; With a score≥17 on the HAMD-1713; With a score≥6 on the BSI14; Without any pharmacotherapy at baseline or maintaining actual pharmacotherapy for at least 2 weeks before the stimulation initiation and during the total stimulation period. Exclusion Criteria: Assessed through applying the Mini-International Neuropsychiatric Interview (MINI)15 by professional psychiatrists that diagnosed any other current or past psychiatric axis-I disorders (except MDD in the patients); Severe liver and kidney diseases, active endocrine diseases or clinical symptoms. Severe cardiovascular disease, respiratory system disease, haematologic diseases and cancer; Any clinically significant abnormal laboratory examination that may influence the health of participants; A history of any aignificant medical illness such as neurological disorders (such as cerebral trauma, seizure disorder, etc); Known current psychosis as determined by the DSM-5 or a history of a non-mood psychotic disorder; Current alcohol and drug abuse; Pregnancy or lactation; Abnormal scalp such as open wounds; HAMD-17 item 3 (suicide) score=4; Receiving modified electroconvulsive therapy (MECT) or repetitive transcranial magnetic stimulation (rTMS) in the past 1 month; Participation in another clinical trial concurrently or no more than 1 month prior to randomisation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiming Chen, Doctor
Phone
(+86)18818210800
Email
chenyiming2012@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiming Chen, Doctor
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiming Chen, Doctor
Phone
(+86)18818210800
Email
chenyiming2012@yeah.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Adjunctive Duration-doubled tDCS for the Treatment of Depressive Patients With Suicidal Ideation

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