The Effectiveness of rTMS in Depressed VA Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this multi-site trial is to determine if repetitive Transcranial Magnetic
      Stimulation (rTMS) helps people with depression who have not been helped by medications or
      who have not been helped enough by medications.
    

Detailed description: 
      Major depression occurs in about 10% of American outpatients every year and of those,
      approximately 20% respond incompletely or not at all to trials of antidepressants, mood
      stabilizers, or psychotherapy (Kaplan and Sadock, 1996; Keller et al 1992; Thase, 2004).
      Treatment as usual for these cases of treatment resistant major depression (TRMD) frequently
      involves increased risks and increased side effects, such as those seen in monoamine oxidase
      inhibitors (MAOIs) and electroconvulsive therapy (ECT). New TRMD treatments are needed,
      preferably without major safety concerns or side effects as seen with aggressive polypharmacy
      or ECT.

      Repetitive transcranial magnetic stimulation (rTMS) is a method of delivering brain
      stimulation without the seizures or risks associated with ECT, nor the potential side effects
      and risks of MAOI therapy. Systematic review and meta-analysis of the studies to date, which
      are typically of a small scale, appear to show a positive effect in TRMD (Martin et al.
      2003). With a minimal side effect profile, and the rarity of untoward events and side-effects
      (Pascual-Leone et al. 1993; Wassermann 1997), safety concerns regarding the use of rTMS are
      considerably less than with ECT. Given this, rTMS has the potential to be a significant
      advance in care, if it were shown to be effective in TRMD in VA patients.

      The trials of rTMS performed to date have not included participants with comorbid disorders,
      such as substance abuse and post-traumatic stress disorder (PTSD), thus the generalizability
      of their findings to a VA population is not clear. Further research including Veterans with
      possible comorbid disorders is necessary, given the high rates of co-occurring substance
      abuse and PTSD that is present in the Veteran population.

      The present study is a randomized, controlled trial that compares active rTMS to a sham
      condition in Veterans with treatment resistant major depression and possible comorbid
      post-traumatic stress disorder (PTSD) and / or a history of substance abuse. Veterans will
      remain under the care of their VA primary mental health provider throughout the project.
      Participants will be assessed at pre-, mid- and several post-treatment time points. This is a
      multisite trial that will be conducted at 9 VA Medical Centers around the country.
    

Intervention name(s): rTMS; Sham Device
Intervention type(s): Device; Device
Intervention description(s): Repetitive Transcranial Magnetic Stimulation; Placebo Device that simulates active rTMS treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mood Disorder; Depression; stress disorder, post-traumatic; Depressive Disorder; Stress Disorders, Traumatic; substance related disorders; Transcranial Magnetic Stimulation, repetitive; transcranial magnetic stimulation; Veterans; mental health