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

NCT05555927 | Unknown

• 1 other identifier: 2021-SMHCYJXYS-06
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• Beck rating scale for suicidal ideation (BSI)

  Change from Baseline BSI at week 1 and week 2

  At week 1 and week 2

Study Arms (2)

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.

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.

Device: transcranial direct current stimulation (tDCS)

Interventions

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.

active tDCS; sham tDCS

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38167178 DERIVED

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Yiming Chen, Doctor

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiming Chen, Doctor

CONTACT

(+86)18818210800; chenyiming2012@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 27, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)