Clinical trial NCT05902312: Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression
Official title: Comparative Effectiveness of Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: MDD
TMS
deep TMS
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, single-center, two-arm, parallel-group superiority trial
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to he effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). The main questions it aims to answer are:

type of study: clinical trial participant population/health conditions : Major Depressive Disorder To assess the superiority of dTMS over rTMS in TRD To evaluate the predictive capacity of scalable candidate biomarkers Participants will be randomly allocated to one of the two intervention groups (rTMS or dTMS).

Detailed description: The primary aim of this trial is to compare the effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). Compared to rTMS, dTMS delivers a broader magnetic field, which in turn reduces coil positioning error and maximizes the probability of optimal cortical stimulation. A past RCT comparing both approaches found a greater depression score decrease and response/remission rates for dTMS, but was short of reaching significance for remission rates (primary outcome). Critical components of this RCT were suboptimal, including too few treatment sessions and insufficient statistical power, both of which could have obscured an actual difference between modalities. Proof of a more effective type of TMS over another would translate into increased odds of improvement for TRD patients who live with a chronic and disabling illness.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Major Depressive Disorder, at least moderate intensity, single or recurrent episode
* HRSD-17 score of at least 18
* No improvement to at least two adequate courses of antidepressants (based on the ATHF) or were unable to tolerate at least two separate trials of antidepressants of inadequate dose and duration
* On a stable antidepressant regimen for the past four weeks before screening
* Patients with a chronic depressive episode \>2 years and who have previously received ECT or ketamine will be eligible to participate

Exclusion Criteria:

* Having previously received TMS;
* Substance use disorder within the last three months
* Diagnosis of bipolar or psychosis spectrum disorder
* Anxiety or personality disorder that is assessed by a study investigator to be the primary cause and causing greater impairment than MDD
* Concomitant major unstable medical or neurological illness
* Intracranial implant, cardiac pacemaker or implanted medication pump
* Significant laboratory abnormality;
* Active suicidal intent
* Pregnancy
* If participating in psychotherapy, must have been in stable treatment for at least three months before entry into the study, with no anticipation of change
* Currently taking more than the equivalent of 2 mg of lorazepam of a benzodiazepine daily or any dose of an anticonvulsant due to the potential to limit TMS effectiveness

Primary outcomes:
measure: Hamilton Rating Scale for Depression-17 (HRSD-17)
timeFrame: Baseline to Week 6
measure: Response (yes/no) on Hamilton Rating Scale for Depression-17
timeFrame: baseline to Week 6
measure: Remission (yes/no) on Hamilton Rating Scale for Depression-17
timeFrame: Week 6
Secondary outcomes:
measure: Hamilton Rating Scale for Depression-17
timeFrame: Baseline to Week 7
measure: Hamilton Rating Scale for Depression-17
timeFrame: Baseline to Week 10
measure: Hamilton Rating Scale for Depression-17
timeFrame: Baseline to Week 18
measure: Response (yes/no) on Hamilton Rating Scale for Depression-17
timeFrame: Baseline to Week 7
measure: Response (yes/no) on Hamilton Rating Scale for Depression-17
timeFrame: Baseline to Week 10
measure: Response (yes/no) on Hamilton Rating Scale for Depression-17
timeFrame: Baseline to Week 18
measure: Remission (yes/no) on Hamilton Rating Scale for Depression-17
timeFrame: Baseline to Week 7
measure: Remission (yes/no) on Hamilton Rating Scale for Depression-17
timeFrame: Baseline to Week 10
measure: Remission (yes/no) on Hamilton Rating Scale for Depression-17
timeFrame: Baseline to Week 18
measure: Hamilton Rating Scale for Depression-28
timeFrame: Baseline to Week 6, Week 7, Week 10, Week 18
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Baseline to Week 6, Week 7, Week 10, Week 18
measure: Quick Inventory of Depressive Symptomatology (self-report) (QIDS-SR 16)
timeFrame: Baseline to Week 6, Week 7, Week 10, Week 18
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline to Week 6, Week 7, Week 10, Week 18
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: Baseline to Week 6, Week 7, Week 10, Week 18
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline to Week 6, Week 7, Week 10, Week 18
measure: Rumination Response Scale (RRS)
timeFrame: Baseline to Week 6, Week 7, Week 10, Week 18
measure: Adult AHDH Self-Report Scale
timeFrame: Baseline to Week 18
measure: McLean Screening Instrument for Borderline Personality Disorder
timeFrame: Baseline
measure: World Health Organization Quality of Life Short Version (WHOQOL-BREF)
timeFrame: Baseline to Week 6, Week 7, Week 10, Week 18
measure: Cognitive Difficulties Scale (MacNair-R)
timeFrame: Baseline to Week 6, Week 7, Week 10, Week 18
measure: Memory Complaints Scale (MacNair)
timeFrame: Baseline to Week 6, Week 7, Week 10, Week 18
measure: Visual Pain Scale
timeFrame: Each treatment day
measure: Sex and Gender scale
timeFrame: Baseline
Other outcomes:
measure: Electroencephalogram to predict treatment response
timeFrame: Baseline
measure: Electroencephalogram event-related potentials
timeFrame: Baseline
measure: Electrocardiogram
timeFrame: Baseline
measure: Pupil measures
timeFrame: Baseline
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
Study officials:
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Jean-Philippe Miron, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: