A Phase 2 interventional study of TMS with Neurostar TMS Therapy System in Major Depressive Disorder, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2013-04-04.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment
rTMS is a promising, though largely untested, option for treating adolescent and young adult depression. This study hypothesizes that rTMS will safely and significantly alleviate depression and decrease suicidal ideation in adolescents and young adults based on previous studies.
After signing consent and undergoing a thorough screening, participants will be administered rTMS 5 days per week for 4 consecutive weeks (a total of 20 sessions) as an add-on to their current antidepressant regime. Adolescents must be accompanied by a parent or legal guardian. We will monitor for depression, anxiety and suicidal ideation over the 4 weeks as well as 1 week following the last rTMS administration using rating scales. These scales will be given once a week, on Fridays, and will require roughly 40 minutes to complete. TMS sessions will last approximately 25 minutes each.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
Browse Depressive Disorder studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Excellent documentation of treatment resistance:
Exclusion Criteria:
Device: TMS with Neurostar TMS Therapy System
20 sessions with 1680 pulses per session at 10 Hz with a 4-second pulse train, stimulation at 100% motor threshold,
Also known as: Neuronetics
Change in depressive level after 4 weeks of rTMS compared with baseline scores. The Hamilton Depression Rating Scale (HDRS) will be used to measure changes in adolescents and young adults.
Time frame: 4 weeks
Change in depressive level using the CDRS (if adolescent) and HDRS (if young adult) at 1-week follow-up compared with baseline scores.
Time frame: 5 weeks
Rates of remission (CDRS≤20; HDRS ≤10) and response (≥40% reduction in CDRS; ≥50% reduction in HDRS) at end of treatment and at follow-up.
Time frame: 5 weeks
Measure across the 4 weeks of rTMS and at 1-week follow-up and compare with baseline scores the following: depressive symptoms, suicidal ideation, anxiety, and Clinical Global Impression-Severity Score (CGI-S).
Time frame: 5 weeks
Safety of rTMS, as defined by maintained participant baseline pretreatment physical and neurological status.
Time frame: 5 weeks
This study is withdrawn, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University