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Search / Trial NCT07033780

Theta-Burst Stimulation to Treat Depression

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Jun 13, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Tms Tbs I Tbs I Tbs Sh I Tbs C I Tbs S Sham I Tbs Spaced I Tbs Compressed I Tbs Ltp Long Term Potentiation Theta Burst Stimulation Intermittent Theta Burst Stimulation Transcranial Magnetic Stimulation Mdd Major Depressive Disorder Depression Depressed Individuals Brain Plasticity Dorsolateral Prefrontal Cortex Dlpfc Motor Cortex Neuroplasticity

ClinConnect Summary

This clinical trial is studying a new way to help people with Major Depressive Disorder (MDD), a type of depression. It is testing a treatment called intermittent theta-burst stimulation (iTBS), which uses gentle magnetic pulses applied to the head to help improve brain activity and reduce depression symptoms. Researchers want to find out which of two different iTBS methods works better at helping the brain change and feel better.

Adults between 18 and 50 years old who have been diagnosed with a current episode of depression and have a certain level of symptoms may be eligible to join. Participants should be on stable antidepressant medication if they are taking any, be right-handed or use both hands equally, and be able to understand and follow the study instructions. During the study, participants will visit the clinic several times over 2 to 3 months. They will receive different iTBS treatments in a random order, have brain scans, complete safety checks, and answer questions about their mood. The goal is to see how their brain and depression symptoms respond to the different treatments. This study is still recruiting participants and aims to help improve future depression treatments.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged 18-50 years old;
  • Must meet criteria for a current Major Depressive Episode (MDE) as ascertained using the Structured Clinical Interview for DSM 5 (SCID-5);
  • Hamilton Rating Scale for Depression (HRSD-17) score \> 7;
  • Must be on a stable antidepressant regimen for a minimum of 4 weeks prior to enrollment, if currently taking antidepressants;
  • Right handed or ambidextrous, assessed using the Edinburgh Handedness Inventory (EHI);
  • Sufficiently proficient in English to complete the required study assessments, as per investigator judgement;
  • Willingness and capacity to provide informed consent;
  • Willingness to comply with all study procedures.
  • Exclusion Criteria:
  • Age 17 years or less, or greater than 51 years old, as brain plasticity is known to be affected by age;
  • Presence of any DSM-5 diagnosis (other than MDD), known to be associated with prefrontal cortical dysfunction, including lifetime diagnoses of bipolar disorder, intellectual disability, or a psychotic disorder, assessed using the SCID-5 and as per investigator judgement;
  • Presence of acute suicidal intent, as determined by the Scale for Suicidal Ideation (SSI);
  • Contradictions to MRI or TMS (e.g., cardiac pacemaker, acoustic device, history of seizures, pregnancy), assessed using the MRI Safety Form and TMS Adult Safety Screen (TASS) and as per investigator judgement;
  • Left handed, assessed using the EHI, to minimize the heterogeneity in cortical excitability and plasticity;
  • Current antipsychotic, antiepileptic, or benzodiazepine use given their potential effects on cortical plasticity, as ascertained through a medication review. An exception will be made if they are taking gabapentin or pregabalin prescribed only for chronic pain, and if the dose had been stable for at least 4 weeks prior to study enrollment.

About Centre For Addiction And Mental Health

The Centre for Addiction and Mental Health (CAMH) is Canada’s leading mental health and addiction teaching hospital, dedicated to advancing research, clinical care, and education in the field of mental health. With a commitment to improving the lives of individuals affected by mental illness and addiction, CAMH conducts innovative clinical trials aimed at developing and evaluating new treatment approaches. The institution fosters a collaborative environment that brings together researchers, clinicians, and community partners to translate scientific findings into effective interventions, ensuring the highest standards of care and support for patients. Through its robust research initiatives, CAMH strives to enhance understanding of mental health disorders and promote evidence-based practices in the treatment of addiction and mental health challenges.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported