Recruiting

a-rTMS

Sponsor:

UCLA

Code:

NCT05645575

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Open-label TMS

Study Details

Brief 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. 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.

Conditions

Major Depressive Disorder

Study ID

NCT05645575

Start date

Apr 1, 2025

Status verified date

Sep, 2025

Completion date

Feb 22, 2027

Anticipated

Primary completion date

Feb 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. All subjects must be between 18-65 years of age.
2. 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.
3. Failure to respond to a minimum of 2 trials of antidepressant medication
4. Failure to respond from at least two different agent classes
5. Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count).
6. Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration.
7. Subjects are willing and able to adhere to the accelerated treatment schedule.

Exclusion Criteria:
8. Are mentally or legally incapacitated, unable to give informed consent
9. Have an infection or poor skin condition over the scalp where the device will be positioned
10. Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure
11. Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
12. 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.
13. 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.)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open-label TMS

Interventions

Open-label TMS

Customized, Open-Label Transcranial Magnetic Stimulation

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) ]

Central Contacts and Locations

Central contacts

Locations

UCLA TMS Service and Research Service

Recruiting

Los Angeles, California, United States, 90024

More Information

Sponsor

University of California, Los Angeles

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-09-23.