Transcranial Direct Current Stimulation for Depression
Recruiting · NCT07042217 · Interventional (participants receive a specific treatment) · Lead sponsor: Soterix Medical
View the official record on ClinicalTrials.gov →Interventions studied
Sham tDCS and Mindfulnesstranscranial direct current stimulation (tDCS) and mindfulness instruction
What this trial is about
This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.
Who can take part
Age range
22 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview
- Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
- QIDS-SR score \>11 on all three days of screening week (Days 1,3, 7)
- Scored at least 17 (inclusive) on the HDRS-17 at trial entry
- Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening
- Female patients are allowed if not pregnant and using a medically acceptable method of contraception, if of childbearing potential.
Exclusion criteria
- Failure to respond to at least 2 antidepressant medications
- Drug or alcohol abuse or dependence in the preceding 3 months
- Concurrent benzodiazepine medication
- High suicide risk assessed during clinician screening at baseline interview.
- Failure to respond to ECT treatment or rTMS treatment in this or any previous episode.
- Current DSM-V-TR psychotic disorder
- History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician
- Metal in the cranium or skull defects
- Implanted pump, neurostimulator, cardiac pacemaker or defibrillator
- Skin lesions on scalp at the proposed electrode sites
- Pregnancy
Where it is running
1 location listed across 1 US state.
- Soterix Medical, Inc. - Woodbridge, New Jersey, United States