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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Device: TMS with Neurostar TMS Therapy System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: rTMS for Adolescent and Young Adult Depression

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active rTMS treatment 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

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

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984087

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Irving Reti, M.B.B.S Johns Hopkins University
  More Information

No publications provided

Responsible Party: Irving Reti, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00984087     History of Changes
Other Study ID Numbers: 21284, NA_00021284
Study First Received: September 23, 2009
Last Updated: April 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
depression
TMS
adolescent
transcranial magnetic stimulation
MDD
Major depression
mood disorders

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014