Recruitment

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