title: Can Medication Free, Treatment-Resistant, Depressed Patients Who Initially Respond to TMS Be Maintained Off Medications? A Prospective, 12-Month Multisite Randomized Pilot Study.
abstract: BACKGROUND
  Repetitive transcranial magnetic stimulation (TMS) is efficacious for acute treatment of resistant major depressive disorder (MDD), but there is little information on maintenance TMS after acute response.
  
  
  OBJECTIVE
  This pilot feasibility study investigated 12-month outcomes comparing two maintenance TMS approaches--a scheduled, single TMS session delivered monthly (SCH) vs. observation only (OBS).
  
  
  METHODS
  Antidepressant-free patients with unipolar, non-psychotic, treatment-resistant MDD participated in a randomized, open-label, multisite trial. Patients meeting protocol-defined criteria for improvement after six weeks of acute TMS were randomized to SCH or OBS regimens. TMS reintroduction was available for symptomatic worsening; all patients remained antidepressant-free during the trial.
  
  
  RESULTS
  Sixty-seven patients enrolled in the acute phase, and 49 (73%) met randomization criteria. Groups were matched, although more patients in the SCH group had failed ≥ 2 antidepressants (p = .035). There were no significant group differences on any outcome measure. SCH patients had nonsignificantly longer time to first TMS reintroduction, 91 ± 66 days, vs. OBS, 77 ± 52 days; OBS patients were nonsignificantly more likely to need reintroduction (odds ratio = 1.21, 95% CI .38-3.89). Reintroduction lasted 14.3 ± 17.8 days (SCH) and 16.9 ± 18.9 days (OBS); 14/18 (78%) SCH and 17/27 (63%) OBS responded to reintroduction. Sixteen patients (32.7%) completed all 53 weeks of the study.
  
  
  CONCLUSIONS
  Maintaining treatment-resistant depressed patients off medications with periodic TMS appears feasible in some cases. There was no statistical advantage of SCH vs. OBS, although SCH was associated with a nonsignificantly longer time to relapse. Those who initially respond to TMS have a strong chance of re-responding if relapse occurs.
authors.affiliation: Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, Providence, RI, USA; Butler Hospital, Providence, RI, USA. Electronic address: Noah_Philip@Brown.edu.
authors.forename: Noah S
authors.initials: NS
authors.lastname: Philip
authors.affiliation: Center for Anxiety and Depression, Mercer Island, WA, USA.
authors.forename: David L
authors.initials: DL
authors.lastname: Dunner
authors.affiliation: Rush University Medical Center, Chicago, IL, USA.
authors.forename: Sheila M
authors.initials: SM
authors.lastname: Dowd
authors.affiliation: Sheppard-Pratt Health System, Baltimore, MD, USA.
authors.forename: Scott T
authors.initials: ST
authors.lastname: Aaronson
authors.affiliation: Neuronetics, Inc, Malvern, PA, USA.
authors.forename: David G
authors.initials: DG
authors.lastname: Brock
authors.affiliation: Butler Hospital, Providence, RI, USA.
authors.forename: Linda L
authors.initials: LL
authors.lastname: Carpenter
authors.affiliation: Neuronetics, Inc, Malvern, PA, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Demitrack
authors.affiliation: University of Nebraska Medical Center/Creighton University, Omaha, NE, USA.
authors.forename: Sarit
authors.initials: S
authors.lastname: Hovav
authors.affiliation: Rush University Medical Center, Chicago, IL, USA.
authors.forename: Philip G
authors.initials: PG
authors.lastname: Janicak
authors.affiliation: Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
authors.forename: Mark S
authors.initials: MS
authors.lastname: George
mesh_terms: D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000008:administration & dosage* / Q000494:pharmacology; D003865:Major Depressive Disorder / Q000628:therapy*; D061218:Depressive Disorder, Treatment-Resistant / Q000628:therapy*; D004351:Drug Resistance; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012008:Recurrence; D019233:Retreatment; D013997:Time Factors; D050781:Transcranial Magnetic Stimulation / Q000379:methods*; D016896:Treatment Outcome; D057832:Watchful Waiting; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents
keywords: Long term outcome; Maintenance of effect; Pilot clinical trial; Transcranial magnetic stimulation