NCT05487911 Cortical rTMS as a Treatment for Depression
| NCT ID | NCT05487911 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-11-01 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-11-01 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Depression is a leading cause of disability worldwide with a 19% lifetime prevalence in the United States. Dysfunctional reward processing is one of the core features of depression. Common treatments of depression include psychological therapies (e.g., cognitive behavioral therapy), medication (e.g., bupropion, sertraline) and psychological therapies and medication combined, but they may not address the function of the reward circuit in depression. These treatments often o not improve depressive symptoms in patients with depression who are classified as having treatment-resistant depression, and they may be unlikely to respond to further medication trials. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation that enables us to selectively excite or inhibit neural activity. Multiple TMS pulses given consecutively are known as repetitive TMS (rTMS), and the primary clinical location for applying rTMS is the left dorsolateral prefrontal cortex (DLPFC) for treatment of depressive symptoms. Many of these studies have shown that rTMS to the DLPFC may result in decreased depressive symptoms, but is only partially effective (response and remission rates of 41.2 and 35.3%, respectively). This evidence supports the importance of evaluating the efficacy of rTMS in other brain regions, such as the orbitofrontal cortex (OFC), in the treatment of depressive symptoms rather than in the DLPFC.
Eligibility Criteria
Inclusion Criteria: 1. Be male or female aged 18-64 years old. 2. Has depressive symptoms according to the PHQ-9 or MADRS or HDRS or SHAPS 3. Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures 4. Female subjects must be non-nursing and not pregnant at the times of fMRI experiments and TMS treatment 5. Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.); Meets the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) 6. Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.); Meets the pre-screening TMS safety questionnaire (Transcranial Magnetic Stimulation Adult Safety Screen - TASS) 7. stabilized with medication treatments (e.g., methadone or buprenorphine) or abstinent from opioids if patients are seeking transition to naltrexone 8. urine toxicity test is negative for specific drugs (e.g., opioids) Exclusion Criteria: 1. In the opinion of the clinician and/or the research team, be expected to fail to complete the study protocol due to not tolerable to receive TMS 2. Unable to understand the design and requirements of the study; 3. Unable to sign informed consent for any reason 4. Has an unstable medical condition, including AIDS, acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency 5. Female subjects who are pregnant or nursing 6. Contraindications to MRI (pacemaker, cochlear implants, metal in the eye, other metal implants, etc.): Do not meet the pre-screening MRI questions provided by the CAMRI at BCM 7. Contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.): Do not meet the pre-screening TMS safety questionnaire (TASS). Additional exclusion criteria for the TMS experiments are based on the recommendations described by the international consensus panel on brain stimulation 8. Non-English speaking subjects (we do not have the staff and/or resources to include other languages); 9. Unstable with medication treatments (e.g., methadone or buprenorphine) 10. urine toxicity test is positive for specific drugs (e.g., opioids) 11. currently on seizure medications (e.g., Depakote)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05487911 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05487911 currently recruiting?
Yes, NCT05487911 is actively recruiting participants. Contact the research team at hoh@menninger.edu for enrollment information.
Where is the NCT05487911 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05487911 clinical trial?
NCT05487911 is sponsored by Baylor College of Medicine. The trial plans to enroll 50 participants.