Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
NCT07033780

Theta-Burst Stimulation to Treat Depression

Led by Centre for Addiction and Mental Health · Updated on 2025-06-24

84

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

C

Centre for Addiction and Mental Health

Lead Sponsor

B

Brain Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to explore the effects of non-invasive brain stimulation protocols using intermittent theta-burst stimulation (iTBS) on brain plasticity and depression severity in depressed individuals aged 18 to 50 years old. Brain plasticity is the brain's ability to change through growth or reorganization. iTBS is a form of transcranial magnetic stimulation (TMS), where magnetic pulses are applied to the scalp using a coil. These pulses pass through the scalp, and can alter brain activity in the area underneath the coil. Based on previous research conducted in animals and humans, researchers believe that iTBS can strengthen the connections between cells in the brain, leading to improved brain plasticity. This trial will compare the effects of the compressed iTBS (iTBS-c) protocol, which is commonly used to treat depression, and the spaced iTBS (iTBS-s) protocol. Researchers want to find out which protocol is better able to produce changes in brain plasticity and improve symptoms of depression among individuals diagnosed with Major Depressive Disorder (MDD). In this trial, participants will be randomized to receive 3 sessions of iTBS-s or iTBS-c, undergo a washout period of at least 2 weeks, then complete 3 sessions of the opposite iTBS intervention. Participants will complete 5 study visits within the span of 2-3 months, including: * Screening assessments to determine eligibility \& 1 sham iTBS (iTBS-sh) session to assess tolerability of the brain stimulation (Visit 1); * 1 Magnetic Resonance Imaging (MRI) brain scan and randomization (Visit 2); * Safety and clinical assessments, iTBS-s or iTBS-c intervention, TMS evoked electroencephalography (TMS-EEG) measurements, and post-iTBS questionnaires (Visits 3-5) followed by a washout period of at least 2 weeks; * Safety and clinical assessments, the opposite iTBS-s or iTBS-c intervention originally randomized to, TMS-EEG measurements, and post-iTBS questionnaires (Visits 6-8).

CONDITIONS

Official Title

Theta-Burst Stimulation to Treat Depression

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-50 years old
  • Meets criteria for a current Major Depressive Episode as determined by SCID-5
  • Hamilton Rating Scale for Depression (HRSD-17) score greater than 7
  • On a stable antidepressant regimen for at least 4 weeks if taking antidepressants
  • Right handed or ambidextrous as assessed by the Edinburgh Handedness Inventory
  • Proficient in English to complete study assessments
  • Willing and able to provide informed consent
  • Willing to comply with all study procedures
Not Eligible

You will not qualify if you...

  • Younger than 18 or older than 50 years old
  • Any DSM-5 diagnosis other than MDD linked to prefrontal dysfunction, including bipolar disorder, intellectual disability, or psychotic disorder
  • Presence of acute suicidal intent
  • Contraindications to MRI or TMS such as pacemaker, acoustic device, history of seizures, or pregnancy
  • Left handedness as assessed by the Edinburgh Handedness Inventory
  • Current use of antipsychotic, antiepileptic, or benzodiazepine medications, except stable dose of gabapentin or pregabalin for chronic pain

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M6J 1H4

Actively Recruiting

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Research Team

C

Christoph Zrenner, MD

CONTACT

D

Dewi Clark, MHSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Theta-Burst Stimulation to Treat Depression | DecenTrialz