Late Life Depression study: TBS
Official title Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression
ClinicalTrials.gov ID: NCT06854367
What this study is testing
- What it's testing
- This study compares how well a faster schedule of brain stimulation works against the standard daily schedule. It also looks at whether specific patterns of stimulation are more effective.
- Who it's for
- The study is looking for older adults who have depression that has not responded well to other treatments.
- What's involved
- Participants will receive a type of brain stimulation called theta burst stimulation (TBS). Some will get multiple sessions per day, while others will get one session per day.
- Time commitment
- The source text does not specify the total duration of the study or the number of visits required.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- are voluntary and competent to consent to treatment
- are an outpatient
- are ≥ 60 years old
- have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of MDD, with a current MDE
- have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of...
You likely can't join if
- have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of substance dependence or abuse within the last 3 months
- have a concomitant major unstable medical illness as determined by one of the study physicians
- have active suicidal intent
- have presumed or probable dementia or clinical evidence of dementia as assessed by Short Blessed Test score ≥ 10
- have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder
- have current psychotic symptoms
See the full eligibility criteria
- are voluntary and competent to consent to treatment
- are an outpatient
- are ≥ 60 years old
- have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of MDD, with a current MDE
- 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...
- have a score ≥ 10 on the Patient Health Questionnaire (PHQ-9)
- have had no increase or initiation of any antidepressant or antipsychotic medication in the 4 weeks prior to screening
- are able to adhere to the treatment schedule
- pass the TMS adult safety screening (TASS) questionnaire
- have a Mini International Neuropsychiatric Interview (MINI 7.0) confirmed diagnosis of substance dependence or abuse within the last 3 months
- have a concomitant major unstable medical illness as determined by one of the study physicians
- have active suicidal intent
- have presumed or probable dementia or clinical evidence of dementia as assessed by Short Blessed Test score ≥ 10
- have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder
- have current psychotic symptoms
- 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...
- have a diagnosis of any personality disorder as assessed by a study investigator to be primary and causing greater impairment than MDD
- did not respond to a course of ECT in the current depressive episode
- have received rTMS in the current episode; patients who have had rTMS in a previous episode would be eligible
- have a history of a primary seizure disorder or a seizure associated with an intracranial lesion
- 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
- have an implanted electronic device that is currently in function such as a defibrillator
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
- have clinically significant laboratory abnormality, in the opinion of a study investigator
- currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.