Depressive DisorderNCT06746857
iTBS-Neurosplasticity for Female Youth With Depression
A study testing repetitive transcranial magnetic stimulation in people with Depressive Disorder, run by University of British Columbia.
Trial summary
- Who is it for?
- Ages 16 to 24 years, women only
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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);
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
TBC
Read the detailed description
TBs
- Conditions
- Depressive Disorder
- Being tested
- repetitive transcranial magnetic stimulation
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
Bilateral dorsolateral prefrontal cortex Intermitten Theta Burst Stimulation to
| Study group | Role | What they receive |
|---|---|---|
| Accelerated iTBS | Experimental | Not described Receives: Device: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale Depression
Minimum score: 0; Maximum score: 52; higher scores mean worse outcome.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Feb 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA, University of British Columbia
- Investigators
- Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746857
- Sponsor's protocol ID
- H22-02593
- Status last verified
- Nov 2025
- First submitted
- 18 Dec 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iTBS-Neurosplasticity for Female Youth With Depression
- ClinicalTrials.gov ID
- NCT06746857
- Acronym / sponsor ID
- H22-02593
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TBC
Detailed description
TBs
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated iTBS | Experimental | Device: repetitive transcranial magnetic stimulation |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulationBilateral dorsolateral prefrontal cortex Intermitten Theta Burst Stimulation to | Device | Accelerated iTBS |
Primary outcome
Hamilton Rating Scale Depression
Time frame: Four weeks
Minimum score: 0; Maximum score: 52; higher scores mean worse outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Depressive Disorder, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Erchov (604-822-1361, ninet.lab@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale Depression (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.