Clinical trial NCT00984087: rTMS for Adolescents and Young Adults
Official title: rTMS for Adolescent and Young Adult Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: depression
TMS
adolescent
transcranial magnetic stimulation
MDD
Major depression
mood disorders
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 decrease suicidal ideation in adolescents and young adults based on previous studies.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in depressive level using the CDRS (if adolescent) and HDRS (if young adult) at 1-week follow-up compared with baseline scores.
timeFrame: 5 weeks
measure: 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.
timeFrame: 5 weeks
measure: 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).
timeFrame: 5 weeks
measure: Safety of rTMS, as defined by maintained participant baseline pretreatment physical and neurological status.
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Irving Reti, M.B.B.S
role: PRINCIPAL_INVESTIGATOR
References: