Suicidal IdeationNCT05555927
Adjunctive Duration-doubled tDCS for the Treatment of Depressive Patients With Suicidal Ideation
A study testing transcranial direct current stimulation (tDCS) in people with Suicidal Ideation, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2024
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Yiming Chen, Doctor, (+86)18818210800, chenyiming2012@yeah.net
About this study
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
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.
Read the 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.
- Conditions
- Suicidal Ideation
- Being tested
- transcranial direct current stimulation (tDCS)
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Experimental | 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. Receives: Device: transcranial direct current stimulation (tDCS) |
| sham tDCS | Sham comparator | 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. Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck rating scale for suicidal ideation (BSI)
Change from Baseline BSI at week 1 and week 2
Measured: At week 1 and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiming Chen, Shanghai Mental Health Center
- Investigators
- Yiming Chen, Doctor, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555927
- Sponsor's protocol ID
- 2021-SMHCYJXYS-06
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Y, Lyu D, Wang F, Huang Q, Yang W, Zhang M, Wei Z, Shi S, Kong S, Chen S, He S, Yang V, Fang Y, Douiri A, Hong W. Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trial. Trials. 2024 Jan 2;25(1):15. doi: 10.1186/s13063-023-07858-0.
PubMed 38167178
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05555927
- Acronym / sponsor ID
- 2021-SMHCYJXYS-06
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Sep 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Experimental | Device: transcranial direct current stimulation (tDCS)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. |
| sham tDCS | Sham comparator | Device: transcranial direct current stimulation (tDCS)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
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 |
|---|---|---|
| transcranial direct current stimulation (tDCS)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. | Device | active tDCS, sham tDCS |
Primary outcome
Beck rating scale for suicidal ideation (BSI)
Time frame: At week 1 and week 2
Change from Baseline BSI at week 1 and week 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Derived from this study: PubMed 38167178Chen Y, Lyu D, Wang F, Huang Q, Yang W, Zhang M, Wei Z, Shi S, Kong S, Chen S, He S, Yang V, Fang Y, Douiri A, Hong W. Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trial. Trials. 2024 Jan 2;25(1):15. doi: 10.1186/s13063-023-07858-0.
- Individual participant dataSharing planned: No
Related trials for Suicidal Ideation
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
SERENE Low-Intensity Focused Ultrasound for Cognitive Control
Suicidal Ideation, Cognitive Control
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors
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.
Yiming Chen, Doctor principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Suicidal Ideation, run by Shanghai Mental Health Center 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 7 inclusion and 11 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 27 Sep 2022. 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 Yiming Chen, Doctor ((+86)18818210800, chenyiming2012@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck rating scale for suicidal ideation (BSI) (time frame: At week 1 and week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05555927, which also lists 1 linked publication.
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 27 Sep 2022.