Clinical trial NCT06172413: Transcranial Alternating Current Stimulation for Treatment-Resistant Depression
Official title: Twice-daily 15 mA Transcranial Alternating Current Stimulation for Treatment-Resistant Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Treatment-Resistant Depression
Keywords: Treatment-Resistant Depression; tACS
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Ningcheng Center Hospital
name: Changning Mental Health Center
name: Tianjin Anding Hospital
name: Kangning Hospital, Ningbo University
First posted: 2023-12-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is an 8-week, multicenter, double-blind, sham-controlled, randomized, parallel-group trial.

TRD is defined as failure of response to at least two antidepressant medication trials based on the Massachusetts General Hospital antidepressant treatment response questionnaire (MGH-ATRQ). Patients will be randomized if they remain moderately ill, assessed by Hamilton Depression Scale-item 17 (HAMD-17) score ≥ 20. The primary outcome is a change in the MADRS total score after four weeks of tACS.

"Remission" is 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.

All participants will receive 40 sessions with stimulation at 77.5 Hz and 15 mA (Active group) or sham stimulation (Sham group).

Each session will last 40 minutes from Monday to Friday at a fixed daytime interval for four continuous weeks.

Eligibility criteria: Inclusion Criteria:

1. 18-65 years old;
2. able to provide written informed consent;
3. 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;
4. failure to respond to at least two antidepressant medication trials based on the MGH-ATRQ;
5. ongoing antidepressant(s) at a fixed dose for at least four weeks before baseline assessment;
6. scored≥20 on the Hamilton Depression Scale-item 17 (HAMD-17) at baseline.

Exclusion Criteria:

1. 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);
2. a treatment history of electroconvulsive therapy (ECT), modified ECT, transcranial direct current stimulation, tACS, deep brain stimulation, and transcranial magnetic stimulation (TMS);
3. risk for suicide (defined as a score of ≥ 3 on the suicide item of HAMD-17);
4. known allergy to electrode materials;
5. inability to communicate with researchers fluently;
6. traumatic brain injury;
7. cerebrovascular or cardiovascular stents;
8. substance use disorder (abuse or dependence, as defined by DSM-IV-TR) in the previous six months;
9. for females, pregnant or breastfeeding, or females of childbearing potential refused to use reliable contraceptive methods during the study;
10. dementia (as defined by Short Blessed \> 10 and/or clinical evidence of dementia);
11. participated in other clinical research within three months before enrollment in this study.

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS): Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score After 4 weeks of Treatment
timeFrame: week 0, 4
Secondary outcomes:
measure: 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
timeFrame: week 0, 4, 8
measure: Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to Week 4 and Week 8.
timeFrame: week 0, 4, 8
measure: Clinical Global Impression-Severity (CGI-S): the change from baseline to Week 4 and Week 8 in Clinical Global Impression- Severity (CGI-S)
timeFrame: week 0, 4, 8
measure: Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 4 and Week 8.
timeFrame: week 4, 8
measure: EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 4 and Week 8 in EQ-5D-5L.
timeFrame: week 0, 4, 8
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Hongxing Wang, MD & PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.