Major Depressive DisorderNCT05172271
Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)
A study testing MagPro TMS Stimulator and coil, Thymatron(R) System IV and Magnetic Resonance Imaging Scanner in people with Major Depressive Disorder and Bipolar Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Unipolar Major Depression
- What is being tested?
- MagPro TMS Stimulator and coil, Thymatron(R) System IV and Magnetic Resonance Imaging Scanner
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following 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.
Show all 41Show fewer
- 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.
- 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.
- Agreement to remain on the same daily dose of all psychiatric medication(s) without taking any new psychiatric medication(s) for a minimum of 6 weeks (42 days) prior to the baseline assessment and through the completion of Study Phase III (Study Phase IV is the 6-month Follow-up Phase) unless advised otherwise by the Investigator
- Agreement that dosage reduction of any medication taken for a psychiatric condition must be completed at least 4 weeks (28 days) prior to the baseline assessment and must remain unchanged thereafter through the completion of Study Phase III (Study Phase IV is the 6- month Follow-up Phase), unless advised otherwise by the Investigator
- Agreement to remain on the same daily dose of psychiatric medication from the start of the baseline assessment / Phase I through the completion of the final treatment Study Phase III (Study Phase IV is the 6-month Follow-up Phase), unless advised otherwise by the Investigator.
- For females of reproductive potential: use of contraception, which in the opinion of the Investigator is highly effective, for at least 1 month prior to screening and agreement to use such a method during study participation, except during the 6-month follow up.
- Ability of the participant to understand and be willing to sign a written informed consent document as determined by the Investigator.
- ECLUSION CRITERIA:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or nursing or women planning to become pregnant during study period, except for the 6-month follow up phase.
- A history of addiction to, dependence on, abuse of, or misuse of alcohol or any controlled, illicit, or illegal substance (excluding nicotine) within the past one year
- Expression of recent or current active suicidal ideas and an explicit plan or intent, in the opinion of the Investigator or answering YES to questions 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) or scoring >4 on Montgomery-Asberg Depression Rating Scale (MADRS) item 10.
- Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise, interfere with, limit, effect or reduce the:
- subject s ability to participate in any of the items listed in the Schedule of Activities
- integrity of the data or
- subject s ability to complete the full duration of the study.
- Mood disorder is, in the opinion of the Investigator, significantly influenced or caused by an underlying medical or neurological condition, for example, multiple sclerosis or fibromyalgia
- History of serious, potentially life-threatening reaction to methohexital or succinylcholine.
- Clinically significant psychiatric comorbidity as determined by clinical interview and in the opinion of the Investigator
- Past or present medical or neurological condition, disease, disorder or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data. Past or present medical or neurological condition, disease, disorder or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.
- History of seizure except those therapeutically induced by ECT, except for childhood febrile seizures.
- History of any of the following:
- intracranial surgery
- cranial metal implants
- presence of devices that may be affected by MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator, vagus nerve stimulator
- history of head trauma associated with a brain imaging study that shows probable or definite evidence of a post-traumatic abnormality as determined by a neuroradiologist and which the Investigator deems clinically significant at screening.
- Any of the following treatment histories:
- Failure to respond to adequate ECT treatment consistent with an ATHF confidence level >=3 in current or any previous episode
- Lifetime history of treatment with deep brain stimulation
- Use of any investigational drug or device within 4 weeks of the screening
- Inability to pass the Evaluation to Sign A Consent Form test for adequate comprehension of the study for any reason including limitations related to use of the English language.
- Positive HIV test.
- Being an NIMH employee or an immediate family member of an NIMH employee.
- Presence of any condition that, in the judgment of the investigator, may hinder completion of the procedures required by the study protocol.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Feasibility Study of Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)
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.
Read more
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.
Read the detailed description
Study Description:
This is a medical device feasibility study, which per FDA definition, is a study focusing primarily on continuing safety data collection that aims to capture preliminary safety and effectiveness data on a near-final or final device design to adequately plan an appropriate pivotal study. It tests the hypothesis that Transcranial Electric Stimulation Therapy (TEST), an experimental brain stimulation therapy, can have an antidepressant effect in individuals with treatment resistant depression (TRD) safely and without significant adverse cognitive effects. TEST involves bifrontal electrical brain stimulation at a dose below the seizure threshold, applied in the same manner as standard electroconvulsive therapy (ECT), with scalp electrodes, under anesthesia, using a standard ECT device. The effects of TEST will be compared to those of sham TEST (anesthesia alone) in 30 patients with TRD in a randomized, double-blind, parallel trial, followed by a nonrandomized extension during which all participants are eligible for active treatment.
Objectives:
Primary Objective: To evaluate the safety and feasibility of TEST in 30 adults with treatment resistant major depression (TRD)
Secondary Objectives: To assess the antidepressant effect of TEST.
Endpoints: Primary Endpoints: 1.Treatment adverse effects with an emphasis on adverse cognitive effects, primarily memory impairment. 2.Presence or absence of a seizure in participants receiving TEST (feasibility of consistently not inducing seizures with TEST)
Secondary Endpoint: Treatment-related changes in depressive symptom scale score
- Being tested
- MagPro TMS Stimulator and coil, Thymatron(R) System IV, Magnetic Resonance Imaging Scanner, ECT device without stimulation
- Keywords
- Electroconvulsive Therapy, Major Depressive Disorder, noninvasive brain stimulation, Bipolar Disorder, SEIZURE
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagPro TMS Stimulator and coilDevice
TMS measurements of cortical excitability pre and post study intervention
Thymatron(R) System IVDevice
The Thymatron(R) System IV (Somatics LLC, Venice, FL, USA) is an FDA 510(k)-cleared ECT device. For TESt, we will be using it in a non FDA-approved manner--stimulating without intending to induce seizures.
Magnetic Resonance Imaging ScannerDevice
Conventional MRI studies in this protocol are considered non-significant risk (NSR) devices. While operated in research mode, the MRI will be under the International Electrotechnical Commission (IEC) 60601-2-33 First Level Controlled Operating Mode, which allows for research pulse sequences to be used within the FDA/IEC safety limits for MRI devices.
ECT device without stimulationOther
Anesthesia alone
| Study group | Role | What they receive |
|---|---|---|
| Sham TEST | Sham comparator | Anesthesia alone Receives: Other: ECT device without stimulation |
| Transcranial Electric Stimulation Therapy (TEST) | Experimental | TEST involves bifrontal electrical brain stimulation at a dose below the seizure threshold, applied in the same manner as standard electroconvulsive therapy (ECT), with scalp electrodes, under anesthesia, using a standard ECT device (modified or unmodified) that can deliver a range of doses below seizure threshold. Receives: Device: MagPro TMS Stimulator and coil; Device: Thymatron(R) System IV; Device: Magnetic Resonance Imaging Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins Verbal Learning Test-Revised (HVLT-R)
The HVLT-R is a brief (<10 min) well-validated version of the word list delayed recall task that assesses anterograde memory.
Measured: 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
change in EEG waveforms from pretreatment session baseline to end of treatment session
This measure will determine the presence or absence of a seizure in participants receiving TEST. It will inform the feasibility of consistently not inducing seizures with TEST.
Measured: every treatment throughout course (approximately 3x weekly)
Secondary outcomes (2)
Montgomery-Asberg Depression Rating Scale (MADRS),
a 10-item, well validated, scale measuring depressive symptoms often used in ECT clinical trials.
Measured: Baseline, after every treatment (approximately 3x weekly) end of Phase II (approximately 2 weeks), end of Phase III (approximately 4-13 weeks), and during outpatient follow up every two weeks for the first month, then monthly for 5 months
Symptoms of Major Depressive Disorder Scale (SMDDS).
The SMDDS is a 16-item, well validated, participant-administered scale that was developed to meet the recommendations promulgated by the FDA to guide industry in the conduct of depression clinical trials
Measured: Baseline, after every treatment (approximately 3x weekly), end of Phase II (approximately 2 weeks), end of Phase III (approximately 4-13 weeks), and during outpatient follow up every two weeks for the first month, then monthly for 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start8 Nov 2022
- Primary completion4 Dec 2025
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William T Regenold, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172271
- Sponsor's protocol ID
- 210031
- Other IDs
- 21-M-0031
- Status last verified
- 10 Aug 2026
- First submitted
- 28 Dec 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Participants can opt in or out of our sharing their data and specimens w/othr researchers through the consent form. If participants opt in, our overall plan is to share a blood specimen and demographic (excluding PII) and clinical information that is deidentified and not linked to a code to which the sample or data can be traced for identification, with Gen ECT consortium which is part of the PGC. The samples and clinical information would be batched and sent once study data is reviewed and locked. Information to accompany the blood sample includes the following: 1. info about the blood sample-date collected 2. demographic information excluding PII 3. Clinical information and study results including the following: psychiatric and medical diagnoses; psychiatric and medical treatment history; substance use history; family history; reason for ECT, details of the ECT course, e.g., number of treatments, electrode placement, and results of cognitive testing and psychiatric scales.
Publications
Prudic J, Sackeim HA, Devanand DP, Krueger RB, Settembrino JM. Acute cognitive effects of subconvulsive electrical stimulation. Convuls Ther. 1994 Mar;10(1):4-24.
PubMed 8055291Sackeim HA. Is the Seizure an Unnecessary Component of Electroconvulsive Therapy? A Startling Possibility. Brain Stimul. 2015 Sep-Oct;8(5):851-4. doi: 10.1016/j.brs.2015.07.026. Epub 2015 Jul 17. No abstract available.
PubMed 26358486Regenold WT, Noorani RJ, Piez D, Patel P. Nonconvulsive Electrotherapy for Treatment Resistant Unipolar and Bipolar Major Depressive Disorder: A Proof-of-concept Trial. Brain Stimul. 2015 Sep-Oct;8(5):855-61. doi: 10.1016/j.brs.2015.06.011. Epub 2015 Jun 26.
PubMed 26187603
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)
- ClinicalTrials.gov ID
- NCT05172271
- Acronym / sponsor ID
- 210031
- Keywords
- Electroconvulsive Therapy, Major Depressive Disorder, noninvasive brain stimulation, Bipolar Disorder, SEIZURE
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
This is a medical device feasibility study, which per FDA definition, is a study focusing primarily on continuing safety data collection that aims to capture preliminary safety and effectiveness data on a near-final or final device design to adequately plan an appropriate pivotal study. It tests the hypothesis that Transcranial Electric Stimulation Therapy (TEST), an experimental brain stimulation therapy, can have an antidepressant effect in individuals with treatment resistant depression (TRD) safely and without significant adverse cognitive effects. TEST involves bifrontal electrical brain stimulation at a dose below the seizure threshold, applied in the same manner as standard electroconvulsive therapy (ECT), with scalp electrodes, under anesthesia, using a standard ECT device. The effects of TEST will be compared to those of sham TEST (anesthesia alone) in 30 patients with TRD in a randomized, double-blind, parallel trial, followed by a nonrandomized extension during which all participants are eligible for active treatment.
Objectives:
Primary Objective: To evaluate the safety and feasibility of TEST in 30 adults with treatment resistant major depression (TRD)
Secondary Objectives: To assess the antidepressant effect of TEST.
Endpoints: Primary Endpoints: 1.Treatment adverse effects with an emphasis on adverse cognitive effects, primarily memory impairment. 2.Presence or absence of a seizure in participants receiving TEST (feasibility of consistently not inducing seizures with TEST)
Secondary Endpoint: Treatment-related changes in depressive symptom scale score
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham TEST | Sham comparator | Other: ECT device without stimulationAnesthesia alone |
| Transcranial Electric Stimulation Therapy (TEST) | Experimental | Device: MagPro TMS Stimulator and coil, Device: Thymatron(R) System IV, Device: Magnetic Resonance Imaging ScannerTEST involves bifrontal electrical brain stimulation at a dose below the seizure threshold, applied in the same manner as standard electroconvulsive therapy (ECT), with scalp electrodes, under anesthesia, using a standard ECT device (modified or unmodified) that can deliver a range of doses below seizure threshold. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (41 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagPro TMS Stimulator and coilTMS measurements of cortical excitability pre and post study intervention | Device | Transcranial Electric Stimulation Therapy (TEST) |
| Thymatron(R) System IVThe Thymatron(R) System IV (Somatics LLC, Venice, FL, USA) is an FDA 510(k)-cleared ECT device. For TESt, we will be using it in a non FDA-approved manner--stimulating without intending to induce seizures. | Device | Transcranial Electric Stimulation Therapy (TEST) |
| Magnetic Resonance Imaging ScannerConventional MRI studies in this protocol are considered non-significant risk (NSR) devices. While operated in research mode, the MRI will be under the International Electrotechnical Commission (IEC) 60601-2-33 First Level Controlled Operating Mode, which allows for research pulse sequences to be used within the FDA/IEC safety limits for MRI devices. | Device | Transcranial Electric Stimulation Therapy (TEST) |
| ECT device without stimulationAnesthesia alone | Other | Sham TEST |
Primary outcome
Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: 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
The HVLT-R is a brief (<10 min) well-validated version of the word list delayed recall task that assesses anterograde memory.
change in EEG waveforms from pretreatment session baseline to end of treatment session
Time frame: every treatment throughout course (approximately 3x weekly)
This measure will determine the presence or absence of a seizure in participants receiving TEST. It will inform the feasibility of consistently not inducing seizures with TEST.
2 secondary outcomes
Montgomery-Asberg Depression Rating Scale (MADRS),
Time frame: Baseline, after every treatment (approximately 3x weekly) end of Phase II (approximately 2 weeks), end of Phase III (approximately 4-13 weeks), and during outpatient follow up every two weeks for the first month, then monthly for 5 months
Symptoms of Major Depressive Disorder Scale (SMDDS).
Time frame: Baseline, after every treatment (approximately 3x weekly), end of Phase II (approximately 2 weeks), end of Phase III (approximately 4-13 weeks), and during outpatient follow up every two weeks for the first month, then monthly for 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 8055291Prudic J, Sackeim HA, Devanand DP, Krueger RB, Settembrino JM. Acute cognitive effects of subconvulsive electrical stimulation. Convuls Ther. 1994 Mar;10(1):4-24.
- Background: PubMed 26358486Sackeim HA. Is the Seizure an Unnecessary Component of Electroconvulsive Therapy? A Startling Possibility. Brain Stimul. 2015 Sep-Oct;8(5):851-4. doi: 10.1016/j.brs.2015.07.026. Epub 2015 Jul 17. No abstract available.
- Background: PubMed 26187603Regenold WT, Noorani RJ, Piez D, Patel P. Nonconvulsive Electrotherapy for Treatment Resistant Unipolar and Bipolar Major Depressive Disorder: A Proof-of-concept Trial. Brain Stimul. 2015 Sep-Oct;8(5):855-61. doi: 10.1016/j.brs.2015.06.011. Epub 2015 Jun 26.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participants can opt in or out of our sharing their data and specimens w/othr researchers through the consent form. If participants opt in, our overall plan is to share a blood specimen and demographic (excluding PII) and clinical information that is deidentified and not linked to a code to which the sample or data can be traced for identification, with Gen ECT consortium which is part of the PGC. The samples and clinical information would be batched and sent once study data is reviewed and locked. Information to accompany the blood sample includes the following: 1. info about the blood sample-date collected 2. demographic information excluding PII 3. Clinical information and study results including the following: psychiatric and medical diagnoses; psychiatric and medical treatment history; substance use history; family history; reason for ECT, details of the ECT course, e.g., number of treatments, electrode placement, and results of cognitive testing and psychiatric scales.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William T Regenold, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagPro TMS Stimulator and coil, Thymatron(R) System IV and Magnetic Resonance Imaging Scanner in people with Major Depressive Disorder and Bipolar Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hopkins Verbal Learning Test-Revised (HVLT-R) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172271, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.