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

Suicidal Ideation Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Suicidal Ideation

• NCT number: NCT05555927
• Study type: Interventional
• Source: Shanghai Mental Health Center
• Contact: Yiming Chen, Doctor
• Phone: (+86)18818210800
• Email: chenyiming2012@yeah.net
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Completion date: December 31, 2024