TEST for Major Depression
Trial Summary
Will I have to stop taking my current medications?
Participants must stay on the same daily dose of their psychiatric medications for at least 6 weeks before starting the trial and throughout the study, unless the investigator advises otherwise. If you need to reduce your medication dosage, it must be done at least 4 weeks before the trial begins.
What data supports the effectiveness of the treatment Transcranial Electric Stimulation Therapy (TEST) for major depression?
Is transcranial electric stimulation therapy (TEST) safe for humans?
How is Transcranial Electric Stimulation Therapy (TEST) different from other treatments for major depression?
Transcranial Electric Stimulation Therapy (TEST), also known as transcranial direct current stimulation (tDCS), is unique because it is a non-invasive brain stimulation technique that modulates brain activity using a low electrical current. Unlike traditional antidepressant medications, it does not involve drugs and can be administered at home under supervision, offering a potential alternative for those who do not respond well to medications.1251112
What is the purpose of this trial?
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.
Research Team
William T Regenold, M.D.
Principal Investigator
National Institute of Mental Health (NIMH)
Eligibility Criteria
Adults aged 25-64 with major depression not improved by standard treatments, including medication or rTMS. They must be stable on current psychiatric medications for at least 4 weeks before and during the trial, agree to use effective contraception if applicable, and not have a history of substance abuse in the past year or certain medical conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase I
Participants receive TEST or sham treatments, with monitoring of safety and feasibility
Treatment Phase II
Continuation of TEST or sham treatments, with further monitoring and assessments
Treatment Phase III
Final phase of TEST or sham treatments, with comprehensive assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Transcranial Electric Stimulation Therapy (TEST)
Transcranial Electric Stimulation Therapy (TEST) is already approved in United States, European Union, Canada for the following indications:
- Major Depressive Disorder
- Chronic Pain
- Stroke Rehabilitation
- Major Depressive Disorder
- Chronic Pain
- Stroke Rehabilitation
- Schizophrenia
- Major Depressive Disorder
- Chronic Pain
- Stroke Rehabilitation
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Mental Health (NIMH)
Lead Sponsor