rTMS for Adolescents and Young Adults

NCT00984087 | Withdrawn Phase 2

• 2 other identifiers: 21284NA_00021284
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

depression; TMS; adolescent; transcranial magnetic stimulation; MDD; Major depression; mood disorders

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

• 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

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

  5 weeks

Study Arms (1)

Active rTMS treatment

EXPERIMENTAL

Device: TMS with Neurostar TMS Therapy System

Interventions

TMS with Neurostar TMS Therapy System DEVICE

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

Also known as: Neuronetics

Active rTMS treatment

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Mood Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Irving Reti, M.B.B.S

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 24, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

US (1)