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rTMS for Depressed Teens: A Sham-Controlled Trial, Part 1 | Clinical Trials | Clareo Health

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rTMS for Depressed Teens: A Sham-Controlled Trial, Part 1

A Randomized, Double-Blinded, Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents

NCT01804270•Paul E. Croarkin

View on ClinicalTrials.gov

Summary

This research proposal aims to better understand the neurobiology of depression in adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically impact brain function and mood. This study will be the first to use a randomized, double-blinded, sham-controlled approach to the investigation of rTMS therapy for depressed adolescents. This approach will allow for the validation of rTMS treatment outcomes in the depressed adolescent population in a scientifically rigorous manner. The magnetic resonance (MR) spectroscopy pattern of rTMS response will be analyzed according to previously established protocols.

Detailed Description

Part 1 of the study aims to: * Evaluate the antidepressant effects of daily, active rTMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode. * Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla(3T), neurometabolic biomarkers at the beginning and end of each study phase. * Define regional specificity \[anterior cingulate (AC) and left dorsolateral prefrontal cortex (L-DLPFC)\] of cerebral metabolites(i.e. glutamate and glutamine) in adolescent depression. * Study whether specific neurochemical resonances are associated with response, remission, and/or maintenance of improvement of clinical depressive symptoms when rTMS is used to treat adolescent depression.

Eligibility

Age

12 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
•Pretreatment CDRS-R Raw score ≥ 40
•Age is at least 12 and less than 22 years
•Ongoing, stable dose antidepressant therapy for at least 6 weeks to include the following antidepressants (with dosing range):
•* Celexa (citalopram hydrobromide) - 10 to 60mg
•* Cymbalta (duloxetine) - 40mg to 120mg
•* Desyrel (trazodone HCl) - 12.5mg to 150mg
•* Effexor (venlafaxine HCl) - 37.5mg to 300mg
•* Luvox (fluvoxamine maleate) - 25mg to 200mg
•* Lexapro (escitalopram oxalate) - 10mg to 40mg
+8 more criteria

Exclusion Criteria

•Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications.
•Prior rTMS, vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT)
•Contraindication to MRI
•Contraindication to rTMS (history of neurological disorder such as seizures, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \>15 minutes, history of stroke, family history of epilepsy, intracardiac lines, Anticoagulant, immune suppressive and/or chemotherapy, or those who received any of these therapies within 3 months before enrollment in the study Unstable medication conditions such as hematological or infectious (e.g., human immunodeficiency virus-HIV) disorders, implanted electronic device, metal in the head, or pregnancy)
•History of schizophrenia, schizoaffective disorder, other \[non mood disorder\] psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), bipolar disorder, psychotic features in this or previous episodes, amnestic disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder
•History of autoimmune, endocrine, viral, or vascular disorder.
•Unstable cardiac disease, uncontrolled hypertension, or sleep apnea
•Active suicidal intent or plan, or history of attempt within the past 6 months

Locations (2)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Key Dates

Start Date

April 1, 2013

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

January 19, 2022

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Repetitive transcranial magnetic stimulation (rTMS)

DEVICE

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

NCT06793397

Major Depressive Disorder (MDD)Depression in Adults+4 more

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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: January 19, 2022Data 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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rTMS for Depressed Teens: A Sham-Controlled Trial, Part 1

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use