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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05902312
Other study ID # 2023-11389
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date September 1, 2027

Study information

Verified date April 2024
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact Jean-Philippe Miron, MD PhD
Phone 514-890-8000
Email jean-philippe.miron@umontreal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 1, 2027
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 21 Years to 70 Years
Eligibility 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

Study Design


Intervention

Device:
transcranial magnetic stimulation
Participants will receive either rTMS or dTMS

Locations

Country Name City State
Canada CHUM Montréal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM) Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Electroencephalogram to predict treatment response individual alpha frequency Baseline
Other Electroencephalogram event-related potentials Reward positivity Baseline
Other Electrocardiogram corrected QT interval Baseline
Other Pupil measures pupil reactivity measures Baseline
Primary Hamilton Rating Scale for Depression-17 (HRSD-17) score change. Higher score means worse outcome. (Min = 0, Max = 53) Baseline to Week 6
Primary Response (yes/no) on Hamilton Rating Scale for Depression-17 Defined as a score reduction of 50% or more baseline to Week 6
Primary Remission (yes/no) on Hamilton Rating Scale for Depression-17 Defined as a score of 7 or less Week 6
Secondary Hamilton Rating Scale for Depression-17 score change. Higher score means worse outcome. (Min = 0, Max = 53) Baseline to Week 7
Secondary Hamilton Rating Scale for Depression-17 score change. Higher score means worse outcome. (Min = 0, Max = 53) Baseline to Week 10
Secondary Hamilton Rating Scale for Depression-17 score change. Higher score means worse outcome. (Min = 0, Max = 53) Baseline to Week 18
Secondary Response (yes/no) on Hamilton Rating Scale for Depression-17 Defined as a score reduction of 50% or more Baseline to Week 7
Secondary Response (yes/no) on Hamilton Rating Scale for Depression-17 Defined as a score reduction of 50% or more Baseline to Week 10
Secondary Response (yes/no) on Hamilton Rating Scale for Depression-17 Defined as a score reduction of 50% or more Baseline to Week 18
Secondary Remission (yes/no) on Hamilton Rating Scale for Depression-17 Defined as a score of 7 or less Baseline to Week 7
Secondary Remission (yes/no) on Hamilton Rating Scale for Depression-17 Defined as a score of 7 or less Baseline to Week 10
Secondary Remission (yes/no) on Hamilton Rating Scale for Depression-17 Defined as a score of 7 or less Baseline to Week 18
Secondary Hamilton Rating Scale for Depression-28 score change. Higher score means worse outcome. (Min = 0, Max = 90) Baseline to Week 6, Week 7, Week 10, Week 18
Secondary Hamilton Anxiety Rating Scale (HAM-A) score change. Higher score means worse outcome. (Min = 0, Max = 56) Baseline to Week 6, Week 7, Week 10, Week 18
Secondary Quick Inventory of Depressive Symptomatology (self-report) (QIDS-SR 16) score change. Higher score means worse outcome. (Min = 0, Max = 42) Baseline to Week 6, Week 7, Week 10, Week 18
Secondary General Anxiety Disorder-7 (GAD-7) score change. Higher score means worse outcome. (Min = 0, Max = 21) Baseline to Week 6, Week 7, Week 10, Week 18
Secondary Snaith-Hamilton Pleasure Scale (SHAPS) score change. Higher score means worse outcome. (Min= 0, Max = 56) Baseline to Week 6, Week 7, Week 10, Week 18
Secondary Columbia-Suicide Severity Rating Scale (C-SSRS) score change. Higher score means worse outcome. (Min = 0, Max = 30) Baseline to Week 6, Week 7, Week 10, Week 18
Secondary Rumination Response Scale (RRS) score change. Higher score means worse outcome. (Min = 0, Max = 88) Baseline to Week 6, Week 7, Week 10, Week 18
Secondary Adult AHDH Self-Report Scale qualitative. Baseline to Week 18
Secondary McLean Screening Instrument for Borderline Personality Disorder score. Higher score means worse outcome. (Min = 0, Max = 10) Baseline
Secondary World Health Organization Quality of Life Short Version (WHOQOL-BREF) Difference score. Lower score means worse outcome. (Min = 26, Max = 130) Baseline to Week 6, Week 7, Week 10, Week 18
Secondary Cognitive Difficulties Scale (MacNair-R) Difference score. Higher score means worse outcome. (Min = 0, Max = 156) Baseline to Week 6, Week 7, Week 10, Week 18
Secondary Memory Complaints Scale (MacNair) score. Higher score means worse outcome. (Min = 0, Max = 45) Baseline to Week 6, Week 7, Week 10, Week 18
Secondary Visual Pain Scale Maximum score (during treatment). Higher score means worse outcome. (Min = 0, Max = 10). Each treatment day
Secondary Sex and Gender scale Descriptive statistics Baseline
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