Recruiting NA Late Life Depression (LLD)

New treatment option for Late Life Depression (LLD)

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: The purpose of this trial is to compare the treatment efficacy (improvement in depressive symptoms) of accelerated TBS protocol (where participants receive multiple TBS treatments daily) to conventional TBS protocol (where participants receive a single TBS treatment daily) in late life depression. In addition, the study also aims to determine if specific patterns of stimulation are more or less effective.

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

Who can join

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

What rules you out

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's taking place

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 - 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?

Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.