No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
10 (estimated)
Sponsor
University of California, San Diego · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 85 who have major depression that hasn't improved with standard treatments. Participants will try a home-based brain stimulation method for two weeks while being supervised remotely.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 85 years old.
I have been diagnosed with Major Depressive Disorder.
I have not responded well to standard antidepressant treatments.
I have a stable internet connection and a compatible device.
You may not be able to join if
I have a history of psychotic or bipolar disorder.
I have significant borderline personality disorder.
I currently have a moderate or severe substance use disorder.
I have a history of significant neurologic disease.
I am pregnant or breastfeeding.
I have unstable medical illness.
I have certain conditions that prevent me from safely receiving the treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability 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. Treatment will be delivered over a 2-week period with daily weekday treatments i.e., five tDCS sess…
The investigators propose a single-arm, open-label study to evaluate the effectiveness, safety, tolerability 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. Treatment will be delivered over a 2-week period with daily weekday treatments i.e., five tDCS sessions, each lasting 20 minutes, spaced by approximately 20-minute inter-session intervals, for a total of three hours a day. Participants will self-administer treatment at home under direct remote supervision. Pre- and post- treatment neurophysiological biomarkers sessions will also be carried out. The study aims to examine changes in mood, brain activity, and related clinical outcomes before, during, and after treatment, with the goal to provide more information that can be used for future studies.
PLEASE NOTE: THERE WILL BE 4 APPOINTMENTS THAT MUST OCCUR IN PERSON IN SAN DIEGO, CA.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. People between the ages of 18 and 85 at the time of screening.
2. Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20.
3. Safe for TMS as measures by the TMS Adult Safety Screening (TASS).
4. Medical records confirming a …
Inclusion Criteria:
1. People between the ages of 18 and 85 at the time of screening.
2. Currently diagnosed with Major Depressive Disorder (MDD) as measured by the MINI and a MADRS score of ≥ 20.
3. Safe for TMS as measures by the TMS Adult Safety Screening (TASS).
4. 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 two inadequate trials (score 1 or 2), without psychiatric illness due to a general medical condition.
5. Stable internet connection and a device compatible with Microsoft Teams.
Exclusion Criteria:
1. History of psychotic or bipolar disorder or depression with psychotic features;
2. Significant borderline personality disorder;
3. Significant comorbid obsessive-compulsive or post-traumatic stress:
4. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal;
5. Clinically significant suicidality disorder;
6. Chronic depression (defined as of over 5 years duration);
7. Pregnancy or lactation, lack of adequate birth control in women of childbearing age;
8. 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 persistent symptoms;
9. Unstable medical illness;
10. Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion);
11. History of TMS (greater than 15 sessions) without a clinically meaningful response.; History of ketamine (greater than 4 sessions) without a clinically meaningful response;
12. Require a benzodiazepine with a dose \> lorazepam 2 mg/day;
13. dermatological conditions contraindicating tDCS;
14. Non-correctable sensory impairments;
15. Inability to consent or participate as an outpatient
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