Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways of using a treatment called Theta Burst Stimulation (TBS) to help improve symptoms of late-life depression, which is depression that occurs in older adults. The researchers want to see if giving TBS multiple times a day (accelerated TBS) is more effective than giving it just once a day (conventional TBS) for people who have not responded well to traditional antidepressant medications. Everyone in the trial will receive treatment, but they will be divided into two groups: one will get the accelerated treatment and the other will receive the conventional treatment.

To join the study, participants need to be at least 60 years old and have a confirmed diagnosis of major depression that has not improved with previous antidepressant treatment. They also need to be able to commit to the treatment schedule and pass a safety screening. Throughout the trial, participants can expect to receive regular TBS treatments and be monitored for their progress. It's important to note that this trial is not yet recruiting participants, so there will be more details available as the study starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. are voluntary and competent to consent to treatment
• • 2. are an outpatient
• • 3. are ≥ 60 years old
• • 4. have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of MDD, with a current MDE
• • 5. have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have failed to tolerate two separate trials of an antidepressant
• • 6. have a score ≥ 10 on the Patient Health Questionnaire (PHQ-9)
• • 7. have had no increase or initiation of any antidepressant or antipsychotic medication in the 4 weeks prior to screening
• • 8. are able to adhere to the treatment schedule
• • 9. pass the TMS adult safety screening (TASS) questionnaire
• Exclusion Criteria:
• • 1. have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of substance dependence or abuse within the last 3 months Protocol Version Number: 2.0 Protocol Version Date:12-Feb-2025 Template Version Date: 19-Jan-2024 Page 19 of 46
• • 2. have a concomitant major unstable medical illness as determined by one of the study physicians
• • 3. have active suicidal intent
• • 4. have presumed or probable dementia or clinical evidence of dementia as assessed by Short Blessed Test score ≥ 10
• • 5. have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder
• • 6. have current psychotic symptoms
• • 7. have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than MDD
• • 8. have a diagnosis of any personality disorder as assessed by a study investigator to be primary and causing greater impairment than MDD
• • 9. did not respond to a course of ECT in the current depressive episode
• • 10. have received rTMS in the current episode; patients who have had rTMS in a previous episode would be eligible
• • 11. have a history of a primary seizure disorder or a seizure associated with an intracranial lesion
• • 12. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
• • 13. have an implanted electronic device that is currently in function such as a defibrillator
• • 14. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
• • 15. have clinically significant laboratory abnormality, in the opinion of a study investigator
• • 16. currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant
• • 17. if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study