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NCT Number: NCT06746857

iTBS-Neurosplasticity for Female Youth With Depression

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Key information

Age range

16 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

TBs

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • are assigned female sex at birth;
  • are 16yo to 24yo;
  • outpatients;
  • are competent to assent (those age 16-18) or consent to participate (those age 19-24);
  • have a Diagnostic and Statistical Manual of Mental Disorders Fifth edition (DSM 5) diagnosis of Major Depressive Episode by Mini-International Neuropsychiatric Interview (MINI) version 7.0.0 for participants aged 18-24 and Adolescents (MINI-KID) for participants aged 16-17;
  • have a score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item) or Depressive symptom severity as shown by a total Children's Depression Rating Scale Revised (CDRS-R) score 40;
  • have not changed dose or initiated a new regular antidepressant or antidepressant augmentation treatment(s) for 4 weeks prior to starting TMS treatment;
  • are able to adhere to the treatment schedule;
  • pass both the TMS and MRI adult safety screening questionnaires.

Exclusion criteria

  • have Moderate or Severe Substance Use Disorder (except tobacco) within the last three (3) months;
  • have a concomitant major unstable medical illness;
  • have active suicidal intent;
  • have not responded to 2 or more adequate trials of antidepressant medication in the current episode as meassured by the ATHF form
  • are pregnant or planning to become pregnant during the study period;
  • have a lifetime (MINI) diagnosis of any psychotic disorder;
  • have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDE;
  • have previously had ECT or rTMS;
  • have any significant neurological disorder or any significant head trauma with clear radiological evidence of cerebrovascular injury on imaging.
  • have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
  • have history of epilepsy
  • are participating in standardized regular psychotherapy provided by a psychiatrist or a registered psychologist for less than 3 months prior to study entry or planning to start during the course of rTMS treatments;
  • have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
  • have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Bilateral dorsolateral prefrontal cortex Intermitten Theta Burst Stimulation to

Primary outcomes

  1. Hamilton Rating Scale Depression

    Time frame: Four weeks

    Minimum score: 0; Maximum score: 52; higher scores mean worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Erchov

CONTACT

[email protected]

604-822-1361

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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