Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression (ACT-LLD)

Center for Addiction and Mental Health (CAMH)

Status

Enrolling

Conditions

Depressive Disorder, Treatment-Resistant

Late Life Depression (LLD)

Mood Disorders

Depression - Major Depressive Disorder

Treatments

Device: TBS

Study type

Interventional

Funder types

Other

Identifiers

NCT06854367

CTO4933

Details and patient eligibility

About

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.

Full description

The purpose of this trial is to compare the treatment efficacy (change in MADRS scores) of accelerated TBS to conventional TBS in participants with moderate to severe LLD at 4-weeks following accelerated TBS or following 30 once daily treatments of conventional TBS. Accelerated TBS group will receive 5 treatment sessions per day at approximately 1 hour intervals for 4 consecutive days on week 1 and 2 non-consecutive days on week 2. Conventional TBS group will receive 30 once daily treatment (approximately 6 weeks). Each treatment will consist of either 1) cTBS of right DLPFC followed by iTBS of left DLPFC; or 2) iTBS of left DLPFC.

Enrollment

280 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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
pass the TMS adult safety screening (TASS) questionnaire

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
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 focus over the duration of the study