iTBS-Neurosplasticity for Female Youth With Depression

NCT06746857 | Not Yet Recruiting

• 1 other identifier: H22-02593
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

TBC

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale Depression

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

  Four weeks

Study Arms (1)

Accelerated iTBS

EXPERIMENTAL

Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation DEVICE

Bilateral dorsolateral prefrontal cortex Intermitten Theta Burst Stimulation to

Accelerated iTBS

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Depressive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Erchov

CONTACT

604-822-1361; ninet.lab@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11