Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression (NCT06854367) | Clinical Trial Compass
RecruitingNot Applicable
Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression
Canada280 participantsStarted 2025-03-27
Plain-language summary
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. To do this, all participants will receive active treatments, but some of the participants in this study will receive accelerated TBS and some will receive once daily TBS.
Who can participate
Age range60 Years
SexALL
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Inclusion 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 trials of an antidepressant
✓. 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
Exclusion criteria
✕. 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 dysthymia, assessed by a study investigator to be primary and causing greater impairment than MDD
✕. have a diagnosis of any personality disorder as assessed by a study investigator to be primary and causing greater impairment than MDD