rTMS for Adolescents and Young Adults

Major Depressive Disorder Clinical Trial

— JHU  

Official title:

rTMS for Adolescent and Young Adult Depression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00984087
• Other study ID #: 21284
• Secondary ID: NA_00021284
• Status: Withdrawn
• Phase: Phase 2
• First received: September 23, 2009
• Last updated: April 1, 2013
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: April 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 24 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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,

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		4 weeks	No
Secondary	Change in depressive level using the CDRS (if adolescent) and HDRS (if young adult) at 1-week follow-up compared with baseline scores.		5 weeks	No
Secondary	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.		5 weeks	No
Secondary	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).		5 weeks	Yes
Secondary	Safety of rTMS, as defined by maintained participant baseline pretreatment physical and neurological status.		5 weeks	Yes