rTMS for Adolescents and Young Adults

Recruitment & Eligibility

Inclusion Criteria

Diagnosed with MDD by a child and adolescent psychiatrist based on the DSM-IV, have a CDRS score of at least 60 or an HDRS score of at least 22 and have been suffering with depression during the current episode for at least 3 months
Currently seeing a Johns Hopkins psychiatrist
Excellent documentation of treatment resistance:
- to at least 2 different antidepressant treatments, defined as resistance to a minimum of two antidepressant drug trials of adequate dose and duration in the current episode or previous episodes, adequacy being defined as a minimum level of three on the ATHF per antidepressant drug trial (those who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to three or more antidepressant medications in the current or a previous episode)
- to at least one course of psychotherapy which did not result in significant alleviation of depressive symptoms
No changes in medication dose or psychotherapy frequency over the previous 1 month
Negative answers on the safety screening questionnaire for rTMS

Exclusion Criteria

History of substance abuse or dependence within the past six months (excluding nicotine and caffeine) or marked conduct disordered or oppositional behavior
Any current unstable medical or surgical illness
Bipolar Disorder
Psychotic symptoms
History of head injury or seizure or history of seizure in a first degree relative.
History of any metal in the head (outside the mouth).
Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps
History of frequent or severe headaches or migraines
History of hearing loss or known history of cochlear implants.
Pregnancy or not using a reliable method of birth control.
Participation in another clinical trial within 30 days of this study
Inability to locate and quantify a motor threshold (MT) as defined by the rTMS protocol
Current use of drugs known to lower seizure threshold, such as stimulants, wellbutrin, bupropion, and certain tricyclics (e.g. clomipramine and maprotiline)
Left-handed

Study & Design

Arm && Interventions

Group	Intervention	Description
Active rTMS treatment	TMS with Neurostar TMS Therapy System	-

Primary Outcome Measures

Name	Time	Method
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.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in depressive level using the CDRS (if adolescent) and HDRS (if young adult) at 1-week follow-up compared with baseline scores.	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.	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).	5 weeks
Safety of rTMS, as defined by maintained participant baseline pretreatment physical and neurological status.	5 weeks

Recruitment & Eligibility