Treatment-Resistant Depression Clinical Trial
Official title:
Twice-daily 15 mA Transcranial Alternating Current Stimulation for Treatment-Resistant Depression
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02497287 -
A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
|
Phase 3 | |
| Recruiting |
NCT03653858 -
Efficacy Study of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression
|
N/A | |
| Recruiting |
NCT02462551 -
Focal Electrically Administered Seizure Therapy for the Treatment of Depression
|
N/A | |
| Recruiting |
NCT01868802 -
Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
|
Phase 2 | |
| Recruiting |
NCT05377177 -
Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI
|
N/A | |
| Completed |
NCT05095792 -
Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
|
||
| Recruiting |
NCT06372834 -
Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients
|
N/A | |
| Active, not recruiting |
NCT03701724 -
Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression
|
N/A | |
| Recruiting |
NCT05800860 -
A Trial of GH001 in Patients With Treatment-resistant Depression
|
Phase 2 | |
| Not yet recruiting |
NCT06404320 -
Physical Activity Program for TRD
|
N/A | |
| Completed |
NCT01945047 -
Action of Ketamine in Treatment-Resistant Depression
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05045378 -
Low-dose Ketamine Infusion Among Adolescents With Treatment-resistant Depression
|
Phase 4 | |
| Completed |
NCT05454410 -
Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD)
|
Phase 2 | |
| Recruiting |
NCT05422417 -
Dorsomedial Prefrontal Neuromodulation in Treatment-resistant Depression
|
N/A | |
| Recruiting |
NCT05842291 -
pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Depression
|
N/A | |
| Recruiting |
NCT04821271 -
Antidepressant Effects of TS-161 in Treatment-Resistant Depression
|
Phase 2 | |
| Active, not recruiting |
NCT04670081 -
Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression
|
Phase 2 | |
| Terminated |
NCT01598324 -
Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder
|
N/A | |
| Recruiting |
NCT05710237 -
Does Psilocybin Require Psychedelic Effects to Treat Depression?
|
Phase 2 | |
| Completed |
NCT03329391 -
Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression
|
N/A |