title: Is S-Adenosyl Methionine (SAMe) for Depression Only Effective in Males? A Re-Analysis of Data from a Randomized Clinical Trial.
abstract: OBJECTIVE
  The aim of this study was to examine whether gender differences may have affected treatment response to S-adenosyl methionine (SAMe) in a recent failed randomized clinical trial (RCT) for adults with major depressive disorder.
  
  
  METHODS
  Data from a 2-site, 12-week, double-blind RCT (n=189) assessing the efficacy of SAMe vs. placebo and a comparator selective serotonin reuptake inhibitor (escitalopram) were subjected to post-hoc analyses to evaluate effects of patient gender on treatment response.
  
  
  RESULTS
  When assessing the efficacy outcomes within each gender separately, SAMe was superior to placebo among males (n=51), but not among females (n=62). Males showed a significant reduction of depression severity from baseline to study endpoint on the 17-item Hamilton Depression Rating Scale (4.3 point difference; p=0.034; d=0.95), while females did not show significant change. This finding emerged despite equivalence on baseline measures of depression severity between the gender groups.
  
  
  CONCLUSIONS
  RESULTS of this secondary data analysis suggest that gender might impact the antidepressant efficacy of SAMe, with greater therapeutic effect found in males. The underlying mechanism is still relatively unknown. Further work is needed to replicate this observation in independent samples.Clinicaltrials.gov identifier: NCT00101452.
authors.affiliation: The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Richmond, Melbourne, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Sarris
authors.affiliation: Mood Disorders Research Program and Laboratory for Clinical and Translational Neuroscience, Butler Hospital, Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.
authors.forename: L H
authors.initials: LH
authors.lastname: Price
authors.affiliation: Mood Disorders Research Program and Laboratory for Clinical and Translational Neuroscience, Butler Hospital, Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.
authors.forename: L L
authors.initials: LL
authors.lastname: Carpenter
authors.affiliation: Mood Disorders Research Program and Laboratory for Clinical and Translational Neuroscience, Butler Hospital, Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, USA.
authors.forename: A R
authors.initials: AR
authors.lastname: Tyrka
authors.affiliation: The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Richmond, Melbourne, Australia.
authors.forename: C H
authors.initials: CH
authors.lastname: Ng
authors.affiliation: Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: G I
authors.initials: GI
authors.lastname: Papakostas
authors.affiliation: Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: A
authors.initials: A
authors.lastname: Jaeger
authors.affiliation: Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Fava
authors.affiliation: Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: D
authors.initials: D
authors.lastname: Mischoulon
mesh_terms: D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D015283:Citalopram / Q000627:therapeutic use; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D012436:S-Adenosylmethionine / Q000627:therapeutic use*; D012727:Sex Characteristics
chemical_list: D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram; D012436:S-Adenosylmethionine