title: Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center.
abstract: BACKGROUND
  Transcranial magnetic stimulation (TMS) is a US Food and Drug Administration-approved treatment for major depressive disorder (MDD) in patients who have not responded to 1 adequate antidepressant trial in the current episode. In a retrospective cohort study, we examined the effectiveness and safety of TMS in the first 100 consecutive patients treated for depression (full DSM-IV criteria for major depressive episode in either major depressive disorder or bipolar disorder) at an academic medical center between July 21, 2008, and March 25, 2011.
  
  
  METHODS
  TMS was flexibly dosed in a course of up to 30 sessions, adjunctive to current medications, for 85 patients treated for acute depression. The primary outcomes were response and remission rates at treatment end point as measured by the Clinical Global Impressions-Improvement scale (CGI-I) at 6 weeks. Secondary outcomes included change in the Hamilton Depression Rating Scale (HDRS); Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR); Beck Depression Inventory (BDI); Beck Anxiety Inventory (BAI); and the Sheehan Disability Scale (SDS). Enduring benefit was assessed over 6 months in patients receiving maintenance TMS treatment. Data from 12 patients who received TMS as maintenance or continuation treatment after prior electroconvulsive therapy (ECT) or TMS given in a clinical trial setting were also reviewed.
  
  
  RESULTS
  The clinical cohort was treatment resistant, with a mean of 3.4 failed adequate trials in the current episode. Thirty-one individuals had received prior lifetime ECT, and 60% had a history of psychiatric hospitalization. The CGI-I response rate was 50.6% and the remission rate was 24.7% at 6 weeks. The mean change was -7.8 points in HDRS score, -5.4 in QIDS-SR, -11.4 in BDI, -5.8 in BAI, and -6.9 in SDS. The HDRS response and remission rates were 41.2% and 35.3%, respectively. Forty-two patients (49%) entered 6 months of maintenance TMS treatment. Sixty-two percent (26/42 patients) maintained their responder status at the last assessment during the maintenance treatment. TMS treatment was well tolerated, with a discontinuation rate of 3% in the acute treatment phase. No serious adverse events related to TMS were observed during acute or maintenance treatment.
  
  
  CONCLUSIONS
  Adjunctive TMS was found to be safe and effective in both acute and maintenance treatment of patients with treatment-resistant depression.
authors.affiliation: Philadelphia VA Medical Center, Department of Behavioral Health, Philadelphia, PA 19104, USA. kevin.connolly2@va.gov
authors.forename: K Ryan
authors.initials: KR
authors.lastname: Connolly
authors.forename: Amanda
authors.initials: A
authors.lastname: Helmer
authors.forename: Mario A
authors.initials: MA
authors.lastname: Cristancho
authors.forename: Pilar
authors.initials: P
authors.lastname: Cristancho
authors.forename: John P
authors.initials: JP
authors.lastname: O'Reardon
mesh_terms: D000046:Academic Medical Centers / Q000706:statistics & numerical data; D001714:Bipolar Disorder / Q000628:therapy; D003865:Major Depressive Disorder / Q000628:therapy*; D004597:Electroshock; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D012074:Remission Induction; D012189:Retrospective Studies; D050781:Transcranial Magnetic Stimulation / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D014481:United States