rTMS for Adolescents and Young Adults (JHU)

Johns Hopkins University

Status and phase

Withdrawn

Phase 2

Conditions

Major Depressive Disorder

Treatments

Device: TMS with Neurostar TMS Therapy System

Study type

Interventional

Funder types

Other

Identifiers

NCT00984087

21284

NA_00021284 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Sex

All

Ages

15 to 24 years old

Volunteers

No Healthy Volunteers

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