Status:
NOT_YET_RECRUITING
Transcranial Alternating Current Stimulation for Treatment-Resistant Depression
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
Ningcheng Center Hospital
Changning Mental Health Center
Conditions:
Treatment-Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
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-...
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 Ma...
Eligibility Criteria
Inclusion
- 18-65 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06172413
Start Date
February 1 2024
End Date
March 31 2025
Last Update
January 31 2024
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