Major Depressive DisorderNCT05645575
In-patient SCC TMS
A study testing Open-label TMS in people with Major Depressive Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The investigators are studying the feasibility, safety, and tolerability of administering accelerated repetitive Transcranial magnetic stimulation(a-rTMS) at frequencies other than standard 10 Hz for in-patient Subjects diagnosed with Major Depressive Disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Open-label TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 22 Feb 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must be between 18-65 years of age.
- Must have confirmed diagnosis of moderate to severe Major Depressive Disorder (single or recurrent episode) as defined by a HAM-D score of 17 or higher.
- Failure to respond to a minimum of 2 trials of antidepressant medication
- Failure to respond from at least two different agent classes
- Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count).
- Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration.
- Subjects are willing and able to adhere to the accelerated treatment schedule.
Who cannot join
- Are mentally or legally incapacitated, unable to give informed consent
- Have an infection or poor skin condition over the scalp where the device will be positioned
- Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure
- Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
- Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.
- Presence of an implanted magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents. (Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with transcranial magnetic stimulation and MRI.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA TMS Service and Research Service
Los Angeles, California, 90024
Nikita Vincecruz, BS
About this study
Official title: Pilot Study: Evaluating the Feasibility of Accelerated rTMS Treatment Delivered at Individual Resonant Frequencies for In-patient Subjects Suffering From Major Depressive Disorder
The investigators are studying the feasibility, safety, and tolerability of administering accelerated repetitive Transcranial magnetic stimulation(a-rTMS) at frequencies other than standard 10 Hz for in-patient Subjects diagnosed with Major Depressive Disorder. Participants will be recruited from the Resnick Neuropsychiatric Hospital. This study will enroll 30 participants who will undergo up to three brain activity recordings, one MRI scan, one TMS procedure to determine the appropriate frequency and intensity for treatment, daily symptom assessments, and 25 TMS treatments. Participants will be asked to participate for up to 2 weeks.
Read the detailed description
Repetitive Transcranial Magnetic Stimulation (rTMS) is an efficacious treatment for Major Depressive Disorder (MDD) and may hold therapeutic potential for suicidality, specifically. The clinical benefit of rTMS is thought to depend upon successful engagement of brain functional networks, which in turn depends on the preferred oscillatory frequency of the target network for that individual.
The investigators have developed a novel interrogation method to identify the optimal individual stimulation frequency for each participant to enhance treatment response by maximizing the engagement of the functional brain networks. Our data suggest that stimulation at individualized frequencies results in about 50% better response for depression compared to the standard treatment of 10 Hz stimulation. Additionally, an accelerated administration of rTMS (a-rTMS) has been shown safe and tolerable, which is highly desirable in the context of a hospitalization.
The investigators propose to use this approach to administer 25 sessions of individualized a-rTMS left dorsolateral prefrontal cortex (DLPFC) over a course of five days to obtain an accelerated relief of depression symptoms and reduce suicide risk. The investigators will enroll 30 in-patients undergoing treatment in the Resnick Neuropsychiatric Hospital. Patients will first undergo a brief (10-15 min) magnetic resonance imaging (MRI) for the purpose of neuronavigation to the optimal anatomical site. Subsequently, a motor threshold will be identified to determine the optimal stimulation intensity. Patients will receive 5 a-rTMS sessions daily for five days with a minimum interval of 1 hour between sessions. In addition to establishing tolerability and acceptability of the intervention, the goal is to evaluate the preliminary efficacy for improving depressive and suicidality symptoms. The investigators expect the treatment to be well tolerated, providing fast relief of depression and suicidal symptoms.
- Conditions
- Major Depressive Disorder
- Being tested
- Open-label TMS
- 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.
Open-label TMSDevice
Also called Transcranial Magnetic Stimulation
Customized, Open-Label Transcranial Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Open-label TMS | Experimental | Not described Receives: Device: Open-label TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy as Measured by Change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Final Visit
Treatment efficacy as measured by change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 84. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Measured: 2 Weeks (Baseline and Final Visit)
Secondary outcomes (1)
Treatment Efficacy as Measured by Change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit.
Treatment efficacy as measured by change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit. This is a 9-item questionnaire with minimum and maximum score values ranging from 0 to 27. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Measured: 2 Weeks (Baseline and Final Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Apr 2025
- Primary completion22 Feb 2027 (estimated)
- Study completion22 Feb 2027 (estimated)
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 California, Los AngelesThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label Transcranial Magnetic Stimulation Treatment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew F. Leuchter, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645575
- Sponsor's protocol ID
- 22-000810
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing is dependent on request by other researchers and relation to study condition and treatment. De-identified study data will be shared at the PI's discretion.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Evaluating the Feasibility of Accelerated rTMS Treatment Delivered at Individual Resonant Frequencies for In-patient Subjects Suffering From Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05645575
- Acronym / sponsor ID
- 22-000810
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 22 Feb 2027 (estimated)
- Study completion
- 22 Feb 2027 (estimated)
- First posted
- 9 Dec 2022 (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.
The investigators are studying the feasibility, safety, and tolerability of administering accelerated repetitive Transcranial magnetic stimulation(a-rTMS) at frequencies other than standard 10 Hz for in-patient Subjects diagnosed with Major Depressive Disorder. Participants will be recruited from the Resnick Neuropsychiatric Hospital. This study will enroll 30 participants who will undergo up to three brain activity recordings, one MRI scan, one TMS procedure to determine the appropriate frequency and intensity for treatment, daily symptom assessments, and 25 TMS treatments. Participants will be asked to participate for up to 2 weeks.
Detailed description
Repetitive Transcranial Magnetic Stimulation (rTMS) is an efficacious treatment for Major Depressive Disorder (MDD) and may hold therapeutic potential for suicidality, specifically. The clinical benefit of rTMS is thought to depend upon successful engagement of brain functional networks, which in turn depends on the preferred oscillatory frequency of the target network for that individual.
The investigators have developed a novel interrogation method to identify the optimal individual stimulation frequency for each participant to enhance treatment response by maximizing the engagement of the functional brain networks. Our data suggest that stimulation at individualized frequencies results in about 50% better response for depression compared to the standard treatment of 10 Hz stimulation. Additionally, an accelerated administration of rTMS (a-rTMS) has been shown safe and tolerable, which is highly desirable in the context of a hospitalization.
The investigators propose to use this approach to administer 25 sessions of individualized a-rTMS left dorsolateral prefrontal cortex (DLPFC) over a course of five days to obtain an accelerated relief of depression symptoms and reduce suicide risk. The investigators will enroll 30 in-patients undergoing treatment in the Resnick Neuropsychiatric Hospital. Patients will first undergo a brief (10-15 min) magnetic resonance imaging (MRI) for the purpose of neuronavigation to the optimal anatomical site. Subsequently, a motor threshold will be identified to determine the optimal stimulation intensity. Patients will receive 5 a-rTMS sessions daily for five days with a minimum interval of 1 hour between sessions. In addition to establishing tolerability and acceptability of the intervention, the goal is to evaluate the preliminary efficacy for improving depressive and suicidality symptoms. The investigators expect the treatment to be well tolerated, providing fast relief of depression and suicidal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label Transcranial Magnetic Stimulation Treatment
| Arm | Type | Receives |
|---|---|---|
| Open-label TMS | Experimental | Device: Open-label TMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All subjects must be between 18-65 years of age.
- Must have confirmed diagnosis of moderate to severe Major Depressive Disorder (single or recurrent episode) as defined by a HAM-D score of 17 or higher.
- Failure to respond to a minimum of 2 trials of antidepressant medication
- Failure to respond from at least two different agent classes
- Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count).
Key exclusion criteria (6 listed)
- Are mentally or legally incapacitated, unable to give informed consent
- Have an infection or poor skin condition over the scalp where the device will be positioned
- Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure
- Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
- Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.
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 |
|---|---|---|
| Open-label TMSAlso: Transcranial Magnetic StimulationCustomized, Open-Label Transcranial Magnetic Stimulation | Device | Open-label TMS |
Primary outcome
Treatment Efficacy as Measured by Change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Final Visit
Time frame: 2 Weeks (Baseline and Final Visit)
Treatment efficacy as measured by change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 84. Higher scores indicate a worse outcome and lower scores indicate better outcome.
1 secondary outcome
Treatment Efficacy as Measured by Change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit.
Time frame: 2 Weeks (Baseline and Final Visit)
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 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Sharing is dependent on request by other researchers and relation to study condition and treatment. De-identified study data will be shared at the PI's discretion.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open-label TMS in people with Major Depressive Disorder, run by University of California, Los Angeles 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Oct 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.
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?
Contact Nikita Vincecruz, BS (310-825-4781, nvincecruz@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Efficacy as Measured by Change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Final Visit (time frame: 2 Weeks (Baseline and Final Visit)). 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 16 Oct 2026.