Personalized accelerated TMS for hospitalized adults with major depression

Pilot Study: Evaluating the Feasibility of Accelerated rTMS Treatment Delivered at Individual Resonant Frequencies for In-patient Subjects Suffering From Major Depressive Disorder

This project will test whether individualized accelerated TMS given over several days helps hospitalized adults with moderate-to-severe major depressive disorder feel better faster.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT05645575 on ClinicalTrials.gov

What this trial studies

Repetitive transcranial magnetic stimulation (rTMS) is an established treatment for major depressive disorder, and clinical benefit likely depends on engaging each person's brain network oscillations. This open-label pilot will enroll 30 inpatients at UCLA's Resnick Neuropsychiatric Hospital who will undergo up to three brain recordings, a brief MRI for neuronavigation, a motor-threshold and frequency-finding TMS procedure, daily symptom ratings, and 25 TMS treatments. Investigators will use a novel method to identify each participant's optimal stimulation frequency and deliver accelerated rTMS (25 sessions over about five days) to the left dorsolateral prefrontal cortex to speed symptom relief. Primary outcomes are feasibility, safety, and tolerability of individualized a-rTMS in hospitalized patients with moderate-to-severe depression.

Who should consider this trial

Good fit: Hospitalized adults age 18–65 with moderate-to-severe major depressive disorder (HAM-D ≥17) who have failed at least two antidepressant trials, received adequate psychotherapy, and used evidence-based augmentation therapies are the intended candidates.

Not a fit: Patients with increased seizure risk, active scalp infection or poor scalp condition, inability to give informed consent, or who cannot tolerate or complete the accelerated schedule are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could provide faster reduction of depressive symptoms and help lower short-term suicide risk for hospitalized patients.

How similar studies have performed: Standard rTMS is proven effective for depression and accelerated rTMS has shown safety and tolerability, while individualized-frequency stimulation is promising with preliminary data suggesting roughly 50% better depression response but is not yet widely validated.

Eligibility criteria

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.)

Where this trial is running

Los Angeles, California

• UCLA TMS Service and Research Service — Los Angeles, California, United States (Recruiting)

Study contacts

• Study coordinator: Nikita Vincecruz, BS

Conditions Major Depressive Disorder