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rTMS for Adolescents and Young Adults (JHU)

This study has been withdrawn prior to enrollment.
(Difficulty with recruitment and therefore funding has been pulled.)
Sponsor:
Information provided by (Responsible Party):
Irving Reti, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00984087
First received: September 23, 2009
Last updated: April 1, 2013
Last verified: April 2013

September 23, 2009
April 1, 2013
October 2009
October 2011   (final data collection date for primary outcome 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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in depressive level after 4 weeks of rTMS compared with baseline scores. The Child Depression Rating Scale (CDRS) and Hamilton Depression Rating Scale (HDRS) will be used to measure changes in adolescents and young adults respectively. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00984087 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Safety of rTMS, as defined by maintained participant baseline pretreatment physical and neurological status. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
rTMS for Adolescents and Young Adults
rTMS for Adolescent and Young Adult Depression

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
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,
Other Name: Neuronetics
Experimental: Active rTMS treatment
Intervention: Device: TMS with Neurostar TMS Therapy System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
15 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00984087
21284, NA_00021284
No
Irving Reti, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Irving Reti, M.B.B.S Johns Hopkins University
Johns Hopkins University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP