title: Risk of adverse events in treatment-resistant depression: propensity-score-matched comparison of antidepressant augment and switch strategies.
abstract: OBJECTIVE
  The objective was to assess differences in adverse events between major depressive patients augmented with a second medication and patients switched to an alternative monotherapy after failing first-step treatment with citalopram.
  
  
  METHODS
  Adverse event profiles for second-step switch and augment medication strategies were compared using public data files from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. In the STAR*D trial, participants failing citalopram selected acceptable next-step strategies and were randomized within acceptable strategies. This design resulted in clinically important differences when comparing across strategies, so a propensity-score-matched sample was created to compare switch (n=269) and augment (n=269) strategies.
  
  
  RESULTS
  Incidence proportions of any adverse event and specific adverse events were similar between the augment and switch groups. The overall incidence proportion of any distressing event was 0.78 [95% confidence interval (CI) 0.72-0.84] in the augment group and 0.80 (95% CI 0.74-0.85) in the switch group. This contrasts unmatched analyses where distressing adverse events were less common in the augment group than the switch group (risk ratio 0.85, 95% CI 0.81-0.90).
  
  
  CONCLUSIONS
  After adjusting for selection bias inherent in the STAR*D comparison of augment with switch, clinically meaningful differences in the adverse event profiles between these treatment strategies were not observed.
authors.affiliation: Department of Pharmacy Care Systems, Harrison School of Pharmacy, Auburn University, 207 Dunstan Hall, Auburn, AL 36849-5506, USA. rah0019@auburn.edu
authors.forename: Richard A
authors.initials: RA
authors.lastname: Hansen
authors.forename: Stacie B
authors.initials: SB
authors.lastname: Dusetzina
authors.forename: Alan R
authors.initials: AR
authors.lastname: Ellis
authors.forename: Til
authors.initials: T
authors.lastname: Stürmer
authors.forename: Joel F
authors.initials: JF
authors.lastname: Farley
authors.forename: Bradley N
authors.initials: BN
authors.lastname: Gaynes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects* / Q000627:therapeutic use; D015283:Citalopram / Q000009:adverse effects* / Q000627:therapeutic use; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment; D014481:United States; D055815:Young Adult
chemical_list: D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram