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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство TBS
  Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neurostimulation that uses focused magnetic field pulses to directly stimulate cortical neurons. Theta burst stimulation (TBS) is a briefer form of patterned rTMS that has been shown to be effective against major depressive disorder. Each treatment will consist of either 1) cTBS of right DLPFC followed by iTBS of left DLPFC; or 2) iTBS of left DLPFC.

Первичные конечные точки

• Depression severity [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

• Depression severity [Срок оценки: up to 10 weeks]
• Depression severity [Срок оценки: up to 10 weeks]
• Anxiety severity [Срок оценки: up to 10 weeks]
• Suicidal ideation [Срок оценки: up to 10 weeks]
• Global cognition [Срок оценки: up to 10 weeks]
• Executive function [Срок оценки: up to 10 weeks]
• Executive function [Срок оценки: up to 10 weeks]
• Memory [Срок оценки: up to 10 weeks]
• Disability and Functional Impairment [Срок оценки: up to 10 weeks]
• Quality of Life Measure [Срок оценки: up to 10 weeks]
• Quality of Life Measure [Срок оценки: up to 10 weeks]
• Participant Expectancy of Improvement and Preference [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• Sunnybrook Health Sciences Centre — Toronto
• Centre for Addiction and Mental Healh — Toronto

Идентификаторы

NCT: NCT06854367 · CTO4933

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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