Transcranial Alternating Current Stimulation for Treatment-Resistant Depression

NCT06172413 | Unknown DMC

• 1 other identifier: TRD-tACS
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial aims to investigate the effect of twice-daily 15 mA transcranial alternating current stimulation (tACS) through three conductive electrodes attached to the scalp in subjects with treatment-resistant depression (TRD). Two hundred adult subjects with TRD will be included in this randomized, double-blind, parallelized, multi-centre study. The primary outcome is the change of the Montgomery-Asberg Depression Rating Scale (MADRS) after four weeks of tACS.

Conditions

Treatment-Resistant Depression

Keywords

Treatment-Resistant Depression; tACS

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS): Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score After 4 weeks of Treatment

  The MADRS has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).

  week 0, 4

Secondary Outcomes (5)

• Montgomery-Asberg Depression Rating Scale (MADRS): remission (defined as MADRS total score ≤10) at Week 4 and Week 8; response is a ≥50% reduction in MADRS total score from baseline to Week 4 and Week 8

  week 0, 4, 8

• Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to Week 4 and Week 8.

  week 0, 4, 8

• Clinical Global Impression-Severity (CGI-S): the change from baseline to Week 4 and Week 8 in Clinical Global Impression- Severity (CGI-S)

  week 0, 4, 8

• Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 4 and Week 8.

  week 4, 8

• EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 4 and Week 8 in EQ-5D-5L.

  week 0, 4, 8

Study Arms (2)

active transcranial alternating current stimulation (tACS)

EXPERIMENTAL

true stimulation.

Device: transcranial alternating current stimulation (tACS)

Sham tACS

SHAM COMPARATOR

no active stimulation

Device: Sham tACS

Interventions

transcranial alternating current stimulation (tACS) DEVICE

Three conductive electrodes will be applied to the scalp: one 4.45 × 9.53 cm electrode placed over the forehead (Fpz, Fp1, and Fp2 in the 10/20 international placement system) and two 3.18 × 3.81 cm electrodes over the mastoid areas. The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. It is a square-wave with an average amplitude of 15 mA and is equally distributed from the frontal region to the mastoid areas (amplitudes are reported as zero-to-peak). Each subject will receive 40 sessions of tACS intervention during 4 consecutive weeks at a fixed day time twice per day (once in morning and afternoon, respectively) from Monday through Friday. Each session lasts 40 min.

active transcranial alternating current stimulation (tACS)

Sham tACS DEVICE

Sham tACS

Sham tACS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• able to provide written informed consent;
• had a diagnosis of major depression disorder (MDD) (recurrent episodes) without psychotic features in compliance with the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revised (DSM-IV-TR) and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0;
• failure to respond to at least two antidepressant medication trials based on the MGH-ATRQ;
• ongoing antidepressant(s) at a fixed dose for at least four weeks before baseline assessment;
• scored≥20 on the Hamilton Depression Scale-item 17 (HAMD-17) at baseline.

You may not qualify if:

• Axis I psychiatric disorders, including schizophrenia, bipolar disorder, manic episodes, anxiety disorders (panic disorder, generalized anxiety disorder, and social anxiety disorder), post-traumatic stress disorder, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, psychosis over the previous six months, and any disorders in Axis II (borderline personality disorder, antisocial personality disorder, schizotypal personality disorder, and narcissistic personality disorder);
• a treatment history of electroconvulsive therapy (ECT), modified ECT, transcranial direct current stimulation, tACS, deep brain stimulation, and transcranial magnetic stimulation (TMS);
• risk for suicide (defined as a score of ≥ 3 on the suicide item of HAMD-17);
• known allergy to electrode materials;
• inability to communicate with researchers fluently;
• traumatic brain injury;
• cerebrovascular or cardiovascular stents;
• substance use disorder (abuse or dependence, as defined by DSM-IV-TR) in the previous six months;
• for females, pregnant or breastfeeding, or females of childbearing potential refused to use reliable contraceptive methods during the study;
• dementia (as defined by Short Blessed \> 10 and/or clinical evidence of dementia);
• participated in other clinical research within three months before enrollment in this study.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Ningcheng Center Hospital: collaborator
• Changning Mental Health Center: collaborator
• Tianjin Anding Hospital: collaborator
• Kangning Hospital, Ningbo University: collaborator

Related Publications (1)

• Zhao W, Wang H, Leng H, Xue Q, Peng M, Jin X, Tan L, Pan N, Wang X, Wang J, Gao K, Zhang X, Wang H. Acute effect of twice-daily 15 mA transcranial alternating current stimulation on treatment-resistant depression: a case series study. Gen Psychiatr. 2023 Nov 10;36(6):e101278. doi: 10.1136/gpsych-2023-101278. eCollection 2023. No abstract available.

  PMID: 38028814 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

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

Study Officials

• Hongxing Wang, MD & PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolei Liu, MD & PhD

CONTACT

+86 10 83198650; ring@vip.163.com

Wenfeng Zhao, MD

CONTACT

+86 13051118863; fengfeng_zw@ccmu.edu.cn

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: Professor, MD & PhD

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01