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Biomarkers in Repetitive Transcranial Magnetic Stimulation (rTMS) for Adolescent Depression

Glutamatergic and GABAergic Biomarkers in rTMS for Adolescent Depression

NCT03363919•Mayo Clinic

Summary

The Researchers are going to gather information regarding the use of rTMS as a treatment for depression in adolescents with Major Depressive Disorder. The researchers also hope to learn if measures of brain activity (cortical excitability and inhibition) collected with transcranial magnetic stimulation (TMS) can be used to identify which patients will benefit from certain types of rTMS treatment.

Detailed Description

Phase I is a double-blind, randomized, biomarker-stratified trial of 1 Hz vs. 10 Hz rTMS. Phase II is for participants who do not respond to Phase I treatment and is a biomarker guided, double-blind trial of continuous vs intermittent theta burst stimulation (TBS). Please note that transcranial magnetic stimulation (TMS) biomarkers will be collected in this protocol during the course of the proposed interventions. Participants in Phase I will be offered enrollment in a separate protocol with baseline and posttreatment 7 Tesla Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) scans

Eligibility

Age

12 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Depressed adolescent participants will have a primary diagnoses of MDD based on a clinical and structured interview with the MINI
•Depression symptoms severity of a 40 or greater based on evaluation with the Children's Depression Rating Scale Revised (CDRS-R) at screening and baseline visits. Further, the total score of the baseline CDRS-R score must not have had a 25% or greater decrease from the screening CDRS-R score
•The duration of the current episode of depression must be 4 weeks or more but 3 years or less.
•For any participant currently receiving antidepressant medication, the referring clinician must determine that insufficient benefit is being received from this treatment and it is clinically appropriate to discontinue the existing antidepressant.
•Participants in psychotherapy are eligible provided that this was initiated 4 weeks prior to enrollment and that the frequency of visits will be maintained during study participation.

Exclusion Criteria

•The following psychiatric comorbidities are exclusionary: psychotic disorders, bipolar disorders, anorexia nervosa, bulimia nervosa, and substance use disorders within the past year (with the exception of caffeine and tobacco)
•A positive urine drug screen at baseline
•Seizure history
•Family history of epilepsy in a first degree relative
•Head trauma with loss of consciousness for greater than 5 minutes
•Any true positive findings on the rTMS safety screening form.
•Any concurrent psychotropic medications (for potential participants receiving antidepressants or psychotropic medications, the referring clinician must determine that insufficient benefit is being received from the treatment and if clinically appropriate, discontinue existing antidepressants and other psychotropic medications)
•Prohibited concomitant medications (See Appendix A)
•Pregnancy or suspected pregnancy in female Participants (assessed with urine pregnancy test)
•Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the subject's head within 30 cm of the treatment coil excluding the mouth that cannot safely be removed. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes.
+7 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

September 24, 2018

Primary Completion Date

March 3, 2023

Completion Date

March 3, 2023

Last Updated

February 1, 2024

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

NeuroStar TMS Therapy® System

DEVICE

NeuroStar XPLOR®

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Biomarkers in Repetitive Transcranial Magnetic Stimulation (rTMS) for Adolescent Depression

Inclusion Criteria

Exclusion Criteria

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