Major Depressive DisorderEarly Phase 1NCT06961851
Feasibility Pilot of Accelerated Stimulation With TMS for Treatment of Major Depressive Disorder (FAST-MDD)
A Early Phase 1 study testing aTMS utilizing the MagVenture TMS device in people with Major Depressive Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
This is a mixed-methods study that includes three steps. The first is a focus group to collect opinions and feedback about implementation of aTMS among clinicians, technicians, nurses, and other clinical staff at the St. Louis Park (SLP) clinic who are experienced with delivering TMS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- aTMS utilizing the MagVenture TMS device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to 1 Feb 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years old
- Current patient of SLP Clinic
- Diagnosis of Unipolar Depression
- Have tried at least 1 antidepressant
- Ability to maintain stable medication regimen for duration of study
Who cannot join
- Has received TMS in the last 3 months
- Diagnosis of Bipolar Depression
- Any lifetime psychosis or mania
- Recent suicide attempt within 90 days of study visit
- Use of Benzodiazepines in past 4 weeks
- Presence of any contraindication to TMS assessed by the TMS Adult Safety Screen including individual history of uncontrolled seizures
- Current or history of alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
This is a mixed-methods study that includes three steps. The first is a focus group to collect opinions and feedback about implementation of aTMS among clinicians, technicians, nurses, and other clinical staff at the St. Louis Park (SLP) clinic who are experienced with delivering TMS. The second is the delivery of a set of questionnaires delivered to TMS patients at the SLP clinic who are awaiting the start of their TMS series. The third is the delivery of aTMS utilizing the MagVenture TMS device to patients on the SLP rTMS waitlist.
The purpose of this feasibility study is to examine the acceptability and efficacy of Accelerated Transcranial Magnetic Stimulation (aTMS) delivered using an accelerated schedule. Repetitive Transcranial Magnetic Stimulation (rTMS) is traditionally delivered once a day, five days a week, for nearly 7 weeks for a total of 36 treatments. While aTMS is quick to deliver, a standard session lasting 10-20 minutes, this schedule is time intensive for patients. It often requires time off from work to accommodate daily driving time to and from the clinic as well as treatment time. This can be disruptive to a patients life and ability to attend all treatment sessions while continuing with their own life responsibilities.
- Conditions
- Major Depressive Disorder
- Being tested
- aTMS utilizing the MagVenture TMS device
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aTMS utilizing the MagVenture TMS deviceOther
Participants will complete 6 MagVenture TMS sessions per day for 5 days at the SLP Clinic. Sessions will take place with at least 30 minutes between each session. The first session will determine the baseline motor threshold for delivering aTMS. We will be stimulating the dorsolateral prefrontal cortex (DLPFC) which is within the FDA approved uses. Participants will complete a PHQ9 on all 5 treatment days and 1, 2, 4, and 6 weeks post treatment via REDCap Participants will complete daily adverse event logs via REDCap
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients with major depressive disorder Receives: Other: aTMS utilizing the MagVenture TMS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in depressive symptoms
assessed via the PHQ9, comparing baseline to end of treatment and 6 weeks post treatment.
Measured: baseline and 6 weeks
Secondary outcomes (2)
Durability data of aTMS
Measured: 0, 1, 2, 4, and 6 weeks post treatment
Dropout rate
will be calculated via completion rates
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start9 Jun 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961851
- Sponsor's protocol ID
- FAST-MDD
- Status last verified
- Feb 2026
- First submitted
- 29 Apr 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Pilot of Accelerated Stimulation With TMS for Treatment of Major Depressive Disorder (FAST-MDD)
- ClinicalTrials.gov ID
- NCT06961851
- Acronym / sponsor ID
- FAST-MDD
- Conditions
- Major Depressive Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 8 May 2025 (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.
This is a mixed-methods study that includes three steps. The first is a focus group to collect opinions and feedback about implementation of aTMS among clinicians, technicians, nurses, and other clinical staff at the St. Louis Park (SLP) clinic who are experienced with delivering TMS. The second is the delivery of a set of questionnaires delivered to TMS patients at the SLP clinic who are awaiting the start of their TMS series. The third is the delivery of aTMS utilizing the MagVenture TMS device to patients on the SLP rTMS waitlist.
The purpose of this feasibility study is to examine the acceptability and efficacy of Accelerated Transcranial Magnetic Stimulation (aTMS) delivered using an accelerated schedule. Repetitive Transcranial Magnetic Stimulation (rTMS) is traditionally delivered once a day, five days a week, for nearly 7 weeks for a total of 36 treatments. While aTMS is quick to deliver, a standard session lasting 10-20 minutes, this schedule is time intensive for patients. It often requires time off from work to accommodate daily driving time to and from the clinic as well as treatment time. This can be disruptive to a patients life and ability to attend all treatment sessions while continuing with their own life responsibilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: aTMS utilizing the MagVenture TMS devicePatients with major depressive disorder |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 70 years old
- Current patient of SLP Clinic
- Diagnosis of Unipolar Depression
- Have tried at least 1 antidepressant
- Ability to maintain stable medication regimen for duration of study
Key exclusion criteria (7 listed)
- Has received TMS in the last 3 months
- Diagnosis of Bipolar Depression
- Any lifetime psychosis or mania
- Recent suicide attempt within 90 days of study visit
- Use of Benzodiazepines in past 4 weeks
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 |
|---|---|---|
| aTMS utilizing the MagVenture TMS deviceParticipants will complete 6 MagVenture TMS sessions per day for 5 days at the SLP Clinic. Sessions will take place with at least 30 minutes between each session. The first session will determine the baseline motor threshold for delivering aTMS. We will be stimulating the dorsolateral prefrontal cortex (DLPFC) which is within the FDA approved uses. Participants will complete a PHQ9 on all 5 treatment days and 1, 2, 4, and 6 weeks post treatment via REDCap Participants will complete daily adverse event logs via REDCap | Other | Study group |
Primary outcome
Reduction in depressive symptoms
Time frame: baseline and 6 weeks
assessed via the PHQ9, comparing baseline to end of treatment and 6 weeks post treatment.
2 secondary outcomes
Durability data of aTMS
Time frame: 0, 1, 2, 4, and 6 weeks post treatment
Dropout rate
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing aTMS utilizing the MagVenture TMS device in people with Major Depressive Disorder, run by University of Minnesota 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 9 Feb 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in depressive symptoms (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2026.