rTMS for Depressed Teens: A Sham-Controlled Trial, Part 2
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Major Depressive Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 21 years
- Gender
- Both males and females
Description
Part 2 of the study aims to: Evaluate the benefit of daily, active, open-label rTMS in Part 1 non-responders. Evaluate the benefits of bi-weekly, active, open-label maintenance rTMS treatment for Part 1 responders over the course of 12 months post acute treatment. Evaluate, by proton magnetic resona...
Part 2 of the study aims to: Evaluate the benefit of daily, active, open-label rTMS in Part 1 non-responders. Evaluate the benefits of bi-weekly, active, open-label maintenance rTMS treatment for Part 1 responders over the course of 12 months post acute treatment. 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.
Tracking Information
- NCT #
- NCT01804296
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Paul E Croarkin, DO Mayo Clinic Principal Investigator: Mark A George, MD Medical University of South Carolina