search
Back to results

rTMS for Adolescents and Young Adults (JHU)

Primary Purpose

Major Depressive Disorder

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TMS with Neurostar TMS Therapy System
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, TMS, adolescent, transcranial magnetic stimulation, MDD, Major depression, mood disorders

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active rTMS treatment

Arm Description

Outcomes

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.

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.
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.
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).
Safety of rTMS, as defined by maintained participant baseline pretreatment physical and neurological status.

Full Information

First Posted
September 23, 2009
Last Updated
April 1, 2013
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT00984087
Brief Title
rTMS for Adolescents and Young Adults
Acronym
JHU
Official Title
rTMS for Adolescent and Young Adult Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty with recruitment and therefore funding has been pulled.
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, TMS, adolescent, transcranial magnetic stimulation, MDD, Major depression, mood disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TMS with Neurostar TMS Therapy System
Other Intervention Name(s)
Neuronetics
Intervention Description
20 sessions with 1680 pulses per session at 10 Hz with a 4-second pulse train, stimulation at 100% motor threshold,
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Safety of rTMS, as defined by maintained participant baseline pretreatment physical and neurological status.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irving Reti, M.B.B.S
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

rTMS for Adolescents and Young Adults

We'll reach out to this number within 24 hrs