Maintenance treatment using rTMS for depression

Maintaining the Acute Therapeutic Effect of rTMS in Treatment-Resistant Depression (Maitr-De)

This study is testing if a type of brain treatment called rTMS can help people with hard-to-treat depression stay feeling better after their initial treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of California, San Diego (other)
• Locations: 3 sites (San Diego, California and 2 other locations)
• Trial ID: NCT06938841 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of maintenance repetitive transcranial magnetic stimulation (rTMS) in individuals with treatment-resistant depression (TRD) who have previously responded to an acute rTMS treatment. It is a double-blind, three-arm trial involving 75 participants across three sites: University of California San Diego, Weill Cornell Medicine, and Australian National University. Participants will be randomized to receive either standard maintenance rTMS, clustered maintenance rTMS, or sham maintenance rTMS over a period of six months, with the primary aim of assessing the efficacy of these treatments in sustaining brain connectivity related to mood regulation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have a diagnosis of major depressive disorder and have previously responded to an acute course of rTMS.

Not a fit: Patients who have not previously responded to rTMS or those with other psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a sustained improvement in mood and functioning for patients with treatment-resistant depression.

How similar studies have performed: Previous studies have shown promising results for rTMS in treating depression, but the maintenance aspect is less explored, making this approach somewhat novel.

Eligibility criteria

Inclusion Criteria:

1. They met criteria for a DSM-5 diagnosis of a Major Depressive Episode (MDE) during the index episode of depression for which they have received an acute rTMS treatment course.
2. Meet criteria for either response or remission from their initial depressive illness. The MINI assessment timeline will be adjusted to allow scoring of illness symptoms prior to rTMS response. Response to acute course of treatment is defined as either a MADRS score of \<10, or a MADRS score of 10-19, plus evidence of having met response criteria on either the MADRS or another structured depression rating scale. The response is defined as a \>50% reduction in the total score from the start to the end of treatment.
3. Their initial rTMS treatment course must have consisted of at least 15 rTMS treatment sessions.
4. People between the ages of 18 and 80 at the time of screening. A written statement from the referring physician will be required to confirm that the participant demonstrates the capacity to consent.
5. Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during TMS-EEG assessments and iTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
6. In good general health, as evidenced by medical history.
7. Agreement to adhere to Lifestyle Considerations throughout study duration.
8. If a person of child-bearing potential is: must take a pregnancy test at the screening visit, with results confirmed as negative by study staff

Exclusion Criteria:

* 1\. Pregnancy 2. History of or current psychotic disorder or depression with psychotic features 3. Severe borderline personality disorder based on clinical assessment. 4. Diagnosis of Intellectual Disability or Autism Spectrum Disorder 5. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal 6. Clinically significant suicidal ideation with plan 7. Any history of ECT (greater than 8 sessions) without a clinical meaningful response in the current episode.

  8\. Recent (during the current depressive episode) or concurrent use of rapid-acting antidepressant agent (i.e., ketamine or a course of ECT) in the last 30 days 9. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma 10. Untreated or insufficiently treated endocrine disorder. 11. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion) 12. Treatment with an investigational drug or other intervention within the study period 13. The patient experiences a relapse between baseline and screening, defined as a moderate depression (MADRS \>=20) and a 25% increase from screening to baseline 14. Require a benzodiazepine with a dose \> lorazepam 2 mg/day or equivalent or any anticonvulsant (with the exception of Gabapentin, pregabalin, and lamotrigine).

Where this trial is running

San Diego, California and 2 other locations

• University of California, San Diego — San Diego, California, United States (RECRUITING)
• Weill Cornell Medicine — New York, New York, United States (RECRUITING)
• Australian National University — Canberra, Australian Capital Territory, Australia (RECRUITING)

Study contacts

• Study coordinator: Interventional Psychiatry

Conditions: Major Depressive Disorder, Treatment Resistant Depression