Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression

Major Depressive Disorder Clinical Trial

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Official title:

Comparative Effectiveness of Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902312
• Other study ID #: 2023-11389
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

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

External Links

•   research website