Theta-burst stimulation for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will compare compressed iTBS (iTBS-c), the commonly used schedule, with spaced iTBS (iTBS-s) in adults aged 18–50 with major depressive disorder. Participants who meet inclusion criteria will receive one of the iTBS protocols delivered to the dorsolateral prefrontal cortex, with neurophysiological and clinical measures collected before and after treatment. Outcomes will include markers of cortical plasticity (LTP-like responses in motor and prefrontal regions) and changes in depression severity using standardized scales. The aim is to identify which timing protocol produces larger and more durable neuroplastic and clinical effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre for Addiction and Mental Health
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Christoph Zrenner, MD
• Email: christoph.zrenner@camh.ca
• Phone: 416-535-8501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.