Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD) (NCT05172271) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)
United States8 participantsStarted 2022-11-08
Plain-language summary
Background:
People with TRD are often helped by electroconvulsive therapy (ECT). But ECT can affect memory and thinking. Researchers want to study a treatment called TEST that uses less electricity.
Objective:
To study the safety and feasibility of TEST and assess its antidepressant effects.
Eligibility:
Adults aged 25-64 with major depression that has not been relieved by current treatments.
Design:
Participants will be admitted to the NIH Clinical Center for 5 18 weeks over 2 3 treatment phases. Their medications may be adjusted.
Participants will be interviewed about their depression, side effects, and other treatments they are receiving. They will complete questionnaires. They will give blood and urine samples. Their brain waves and heart rhythm will be recorded. They will take tests of memory, attention, mental functioning, and thinking.
Participants will have magnetic resonance imaging (MRI) scans of the head and brain. They will lie on a table that slides in and out of the scanner. Pictures of brain chemicals will also be taken. They may complete tasks during the MRI.
Participants will receive TEST and/or sham treatments. They may receive optional ECT. An intravenous catheter will be placed in an arm vein to receive general anesthesia. Two electrodes will be placed on the front of their head. An electric current will be passed from the ECT machine through the electrodes. For sham treatments, they will not receive the electric current. Their breathing, heart rate, brain function, blood pressure, and body movements will be measured.
Participants will have 7 follow-up visits over 6 months. Visits can be done via telehealth.
Participation will last for up to 42 weeks.
Who can participate
Age range
25 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of a signed and dated informed consent form.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Male or female, ages 25 through 64 years.
. Meeting structured clinical interview for the DSM 5 (SCID) criteria for major depressive disorder, bipolar I disorder, or bipolar II disorder.
. Currently have TRD as defined by a major depressive episode with lack of remission of depressive symptoms following two trials of different medication or one medication trial and one rTMS trial approved for unipolar or bipolar depression at adequate dosage and duration treatment consistent with an Antidepressant Treatment History Form (ATHF) confidence level \>=3.
. Score \>= 25 on the Montgomery-Asberg Depression Rating Scale (MADRS) and a score \>=2 on item 1 at screening or for individuals with bipolar depression, score \>= 25 on the Bipolar Depression Rating Scale (BDRS) at screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying transcranial electric stimulation for treatment-resistant depression — since I've already tried other treatments that haven't worked, is this approach something worth discussing as a next step, or are there standard options I should try first?
2The trial is measuring memory using the Hopkins Verbal Learning Test, which suggests memory changes are a key concern — what does that tell us about the known or potential cognitive risks of transcranial electric stimulation, and how might that affect me personally?
3The trial is listed as 'active not recruiting,' meaning they're no longer enrolling new patients — are there similar transcranial electric stimulation studies that are currently open, or is there another way I could access this type of treatment?
4This trial includes people with both unipolar major depression and bipolar disorder — given my specific diagnosis, how would my doctor think about whether transcranial electric stimulation is appropriate for my situation compared to someone with a different diagnosis in that group?
5The trial is listed as Phase NA, which is unusual — what does that mean for how much is already known about the safety and effectiveness of this particular approach, and how should that affect how cautiously I think about it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hopkins Verbal Learning Test-Revised (HVLT-R)
Timeframe: Baseline, End of Phase II (approximately 2 weeks) and end of Phase III (4-13 weeks) and at 2 and 4 weeks post treatment course
2
change in EEG waveforms from pretreatment session baseline to end of treatment session
Timeframe: every treatment throughout course (approximately 3x weekly)
. Score \<=12 on the Young Mania Rating Scale (YMRS) and a score \<= 1 on item 1 at screening.
. Willingness to: (a) provide written permission, as requested, to allow any and all forms of communication between the Investigator/Research Staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within two years of study enrollment; and (b) provide the name and verifiable contact information of a person whom they trust to be an emergency contact whom research staff is at liberty to contact for the duration of study participation and who could serve as a legally authorized representative (LAR) if needed.