Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01502033|
Recruitment Status : Completed
First Posted : December 30, 2011
Results First Posted : February 17, 2016
Last Update Posted : April 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Transcranial Magnetic Stimulation||Not Applicable|
This study aims to:
- Evaluate the antidepressant effect and safety of rTMS in adolescents meeting criteria for major depressive disorder, single or recurrent episode.
- Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla (3T), the regional specificity [anterior cingulate (AC) vs. left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites (glutamate and glutamine) in adolescent depression and study whether glutamine resonances are associated with response or remission of clinical depressive symptoms when rTMS is used to treat adolescent depression.
- Evaluate the accuracy of an efficient method for locating the F3 position (i.e., L-DLPFC) through comparison with magnetic resonance imaging (MRI).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Eight-Week Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents: Mechanisms of Response|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Transcranial Magnetic Stimulation
Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
Device: Transcranial Magnetic Stimulation
30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment
Other Name: NeuroStar
- Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal) [ Time Frame: 5 days of Treatment 30 or Last Treatment ]The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.
- Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal) [ Time Frame: Within 5 days of Treatment 30 or Last Treatment ]The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).
- The Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Within 5 days of 30 treatments or after last treatment in case of early withdrawal ]The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502033
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Paul E Croarkin, DO||Mayo Clinic|