Trial studying safety and effects for Treatment Resistant Depression (TRD)
Official title Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Feasibility and Safety Study
ClinicalTrials.gov ID: NCT07217223
What this study is testing
- What it's testing
- The investigators propose a single-arm, study to look at the effectiveness, safety, side effects and feasibility of at-home transcranial direct current stimulation (tDCS) as a treatment for depression, particularly in cases where patients have not responded well to traditional therapies.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- People between the ages of 18 and 85 at the time of screening.
- Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20.
- Safe for TMS as measures by the TMS Adult Safety Screening (TASS).
- Medical records confirming a history of failing to achieve clinical response to an adequate antidepressant trial as defined an Antidepressant...
- Stable internet connection and a device compatible with Microsoft Teams.
You likely can't join if
- History of psychotic or bipolar disorder or depression with psychotic features;
- Significant borderline personality disorder;
- Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
- Clinically significant suicidality disorder;
- Chronic depression (defined as of over 5 years duration);
- Pregnancy or lactation, lack of adequate birth control in women of childbearing age;
See the full eligibility criteria
- People between the ages of 18 and 85 at the time of screening.
- Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20.
- Safe for TMS as measures by the TMS Adult Safety Screening (TASS).
- Medical records confirming a history of failing to achieve clinical response to an adequate antidepressant trial as defined an Antidepressant Treatment History Form (ATHF) score ≥ 3 or ) or shown intolerance to at least...
- Stable internet connection and a device compatible with Microsoft Teams.
- History of psychotic or bipolar disorder or depression with psychotic features;
- Significant borderline personality disorder;
- Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
- Clinically significant suicidality disorder;
- Chronic depression (defined as of over 5 years duration);
- Pregnancy or lactation, lack of adequate birth control in women of childbearing age;
- History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with...
- Unstable medical illness;
- Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion);
- History of TMS (greater than 15 sessions) without a clinically meaningful response.; History of ketamine (greater than 4 sessions) without a clinically meaningful response;
- Require a benzodiazepine with a dose \> lorazepam 2 mg/day;
- dermatological conditions contraindicating tDCS;
- Non-correctable sensory impairments;
- Inability to consent or participate as an outpatient
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.