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Transcranial Alternating Current Stimulation for Treatment-Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06172413
Recruitment Status : Not yet recruiting
First Posted : December 15, 2023
Last Update Posted : January 31, 2024
Sponsor:
Collaborators:
Ningcheng Center Hospital
Changning Mental Health Center
Tianjin Anding Hospital
Kangning Hospital, Ningbo University
Information provided by (Responsible Party):
wanghongxing, Xuanwu Hospital, Beijing

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.

Condition or disease Intervention/treatment Phase
Treatment-Resistant Depression Device: transcranial alternating current stimulation (tACS) Device: Sham tACS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Twice-daily 15 mA Transcranial Alternating Current Stimulation for Treatment-Resistant Depression
Estimated Study Start Date : February 1, 2024
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : March 31, 2025


Arm Intervention/treatment
Experimental: active transcranial alternating current stimulation (tACS)
true stimulation.
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 Comparator: Sham tACS
no active stimulation
Device: Sham tACS
Sham tACS




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS): Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score After 4 weeks of Treatment [ Time Frame: week 0, 4 ]
    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).


Secondary Outcome Measures :
  1. 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 [ Time Frame: week 0, 4, 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).

  2. Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to Week 4 and Week 8. [ Time Frame: week 0, 4, 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.

  3. Clinical Global Impression-Severity (CGI-S): the change from baseline to Week 4 and Week 8 in Clinical Global Impression- Severity (CGI-S) [ Time Frame: week 0, 4, 8 ]
    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.

  4. Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 4 and Week 8. [ Time Frame: week 4, 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.

  5. EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 4 and Week 8 in EQ-5D-5L. [ Time Frame: week 0, 4, 8 ]
    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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06172413


Contacts
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Contact: Xiaolei Liu, MD & PhD +86 10 83198650 ring@vip.163.com
Contact: Wenfeng Zhao, MD +86 13051118863 fengfeng_zw@ccmu.edu.cn

Sponsors and Collaborators
Xuanwu Hospital, Beijing
Ningcheng Center Hospital
Changning Mental Health Center
Tianjin Anding Hospital
Kangning Hospital, Ningbo University
Investigators
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Principal Investigator: Hongxing Wang, MD & PhD Xuanwu Hospital, Beijing
Additional Information:
Publications:
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Responsible Party: wanghongxing, Professor, MD & PhD, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT06172413    
Other Study ID Numbers: TRD-tACS
First Posted: December 15, 2023    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by wanghongxing, Xuanwu Hospital, Beijing:
Treatment-Resistant Depression; tACS
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders