rTMS for Adolescents and Young Adults

NCT ID: NCT00984087

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-10-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active rTMS treatment

Group Type: EXPERIMENTAL

TMS with Neurostar TMS Therapy System

Intervention Type: DEVICE

20 sessions with 1680 pulses per session at 10 Hz with a 4-second pulse train, stimulation at 100% motor threshold,

Interventions

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,

Intervention Type: DEVICE

Other Intervention Names

Neuronetics

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Irving Reti

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irving Reti, M.B.B.S

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00021284

Identifier Type: OTHER

Identifier Source: secondary_id

21284

Identifier Type: -

Identifier Source: org_study_id