Transcranial Alternating Current Stimulation for Treatment-Resistant Depression

Treatment-Resistant Depression Clinical Trial

Official title:

Twice-daily 15 mA Transcranial Alternating Current Stimulation for Treatment-Resistant Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172413
• Other study ID #: TRD-tACS
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: Xuanwu Hospital, Beijing
• Contact: Xiaolei Liu, MD & PhD
• Phone: +86 10 83198650
• Email: ring[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment-Resistant Depression

Intervention

Device:
• transcranial alternating current stimulation (tACS)
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.
• Sham tACS
Sham tACS

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Changning Mental Health Center, Kangning Hospital, Ningbo University, Ningcheng Center Hospital, Tianjin Anding Hospital

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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, 8
Secondary	Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to Week 4 and Week 8.	HAMD-17 ranges from 0 to 52, with higher scores indicating more depression; a score of 20 or more indicates a moderate to severe depression.	week 0, 4, 8
Secondary	Clinical Global Impression-Severity (CGI-S): the change from baseline to Week 4 and Week 8 in Clinical Global Impression- Severity (CGI-S)	The clinical global impression-severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. Score 1 presents normal, not at all ill, and score 7 presents among the most extremely ill patients.	week 0, 4, 8
Secondary	Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 4 and Week 8.	The clinical global impression-improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Score 1 presents the patient as much improved, and score 7 presents much worse.	week 4, 8
Secondary	EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 4 and Week 8 in EQ-5D-5L.	EQ-5D-5L is an instrument which evaluates the generic quality of life. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The score ranges from 5 (having no problems) to 25 (being unable to do/having extreme problems).	week 0, 4, 8

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