Status:
WITHDRAWN
rTMS for Adolescents and Young Adults
Lead Sponsor:
Johns Hopkins University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
15-24 years
Phase:
PHASE2
Brief Summary
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 decrea...
Detailed Description
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 antidep...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00984087
Start Date
October 1 2009
End Date
October 1 2011
Last Update
April 4 2013
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287