An Evaluation of Safety and Feasibility Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression
The objective of this investigation is to examine the safety and feasibility of a series of repetitive transcranial magnetic stimulation (rTMS) treatments (10 Hertz [Hz]; Left Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 Therapy System as adjuvant treatment for depression in adolescent subjects.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression|
- Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2) [ Time Frame: Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit) ] [ Designated as safety issue: Yes ]The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.
- Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R) [ Time Frame: At study visit 30 ] [ Designated as safety issue: No ]The Children's Depression Rating Scale, Revised (CDRS-R) is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. Scores range from 0 to 60, with the following scale: not depressed (<20), borderline depressive symptoms (20-29), mild depression (30-39), moderate depression (40-59), severe depression (>/=60).
|Study Start Date:||May 2007|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: rTMS Treatment
All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
Device: rTMS Treatment
Active rTMS treatment.
Other Name: Neuronetics Model 2100 Therapy System
High frequency rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) has been shown to have an antidepressant effect. Initial studies comparing electroconvulsive therapy (ECT) and rTMS suggest that rTMS has been as effective as ECT in treating non-psychotic depression. Given the high degree of ongoing dysfunction in depressed adolescents despite optimization of treatment with antidepressant medications, new concerns regarding suicidal thoughts and behaviors in adolescents treated with antidepressant medications, and the more interventional nature of ECT, the use of rTMS as adjuvant therapy may be of significant clinical benefit. Thus far, research using rTMS to treat depression in adolescents has been limited. The primary aim of this study is to examine the safety and feasibility of using 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in adolescents.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587639
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Shirlene M. Sampson, M.D.||Mayo Clinic|
|Principal Investigator:||Christopher A. Wall, M.D.||Mayo Clinic|