Clinical trial NCT06746857: ITBS-Neurosplasticity for Female Youth with Depression
Official title: ITBS-Neurosplasticity for Female Youth with Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 8
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TBC

Detailed description: TBs

Eligibility criteria: Inclusion Criteria:

1. are assigned female sex at birth;
2. are 14yo to 24yo;
3. outpatients;
4. are competent to assent (those age 14-18) or consent to participate (those age 19-24);
5. 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 14-17;
6. 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;
7. have not changed dose or initiated a new regular antidepressant or antidepressant augmentation treatment(s) for 4 weeks prior to starting TMS treatment;
8. are able to adhere to the treatment schedule;
9. pass both the TMS and MRI adult safety screening questionnaires.

Exclusion Criteria:

1. have Moderate or Severe Substance Use Disorder (except tobacco) within the last three (3) months;
2. have a concomitant major unstable medical illness;
3. have active suicidal intent;
4. have not responded to 2 or more adequate trials of antidepressant medication in the current episode as meassured by the ATHF form
5. are pregnant or planning to become pregnant during the study period;
6. have a lifetime (MINI) diagnosis of any psychotic disorder;
7. have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDE;
8. have previously had ECT or rTMS;
9. have any significant neurological disorder or any significant head trauma with clear radiological evidence of cerebrovascular injury on imaging.
10. 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;
11. have history of epilepsy
12. 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;
13. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
14. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);

Primary outcomes:
measure: Hamilton Rating Scale Depression
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA
role: PRINCIPAL_INVESTIGATOR
References: