NCT05645575 · University of California, Los Angeles
In-patient SCC TMS
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Open-label TMS
Customized, Open-Label Transcranial Magnetic Stimulation
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.)
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2025 · Source of record for eligibility and locations