Not yet recruiting NCT06746857

iTBS-Neurosplasticity for Female Youth With Depression

No phase Interventional Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: repetitive transcranial magnetic stimulation.
Who it may be relevant to: Registry conditions: Depressive Disorder. Basic parameters: 16 years — 24 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

TBC

Detailed description

TBs

Device repetitive transcranial magnetic stimulation
Bilateral dorsolateral prefrontal cortex Intermitten Theta Burst Stimulation to

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.

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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Center list to be confirmed — check the primary protocol.

NCT: NCT06746857 · H22-02593