ITBS-Neurosplasticity for Female Youth with Depression

NCT ID: NCT06746857

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-08-30

Brief Summary

TBC

Detailed Description

TBs

Conditions

Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Accelerated iTBS

Group Type: EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Bilateral dorsolateral prefrontal cortex Intermitten Theta Burst Stimulation to

Interventions

repetitive transcranial magnetic stimulation

Bilateral dorsolateral prefrontal cortex Intermitten Theta Burst Stimulation to

Intervention Type: DEVICE

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);

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Fidel Vila-Rodriguez

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Central Contacts

Alice Erchov

Role: CONTACT

Phone: 604-822-1361

Email: ninet.lab@ubc.ca

Other Identifiers

H22-02593

Identifier Type: -

Identifier Source: org_study_id