S-Adenosyl Methionine (SAMe) Augmentation of Serotonin Reuptake Inhibitors for Antidepressant Nonresponders With Major Depressive Disorder: A Double-Blind, Randomized Clinical Trial

The results of this study provide preliminary evidence suggesting that S-adenosyl methionine can be an effective, relatively well-tolerated, and safe adjunctive treatment strategy for serotonin reuptake inhibitor nonresponders with major depressive disorder, and our findings warrant replication

George I. Papakostas; David Mischoulon; Irene Shyu; Jonathan E. Alpert; Maurizio Fava

2010

Scholarcy highlights

  • Despite the progressive increase in the number of antidepressants, many patients with major depressive disorder continue to be symptomatic
  • The Hamilton Depression Rating Scale response and remission rates were higher for patients treated with adjunctive S-adenosyl methionine than adjunctive placebo
  • There was no statistically significant difference in the proportion of SAMe- versus placebo-treated patients who discontinued the trial for any reason, due to adverse events, or due to inefficacy
  • These preliminary results suggest that SAMe can be an effective, well-tolerated, and safe adjunctive treatment strategy for serotonin reuptake inhibitor nonresponders with major depressive disorder and warrant replication
  • The results of this study provide preliminary evidence suggesting that SAMe can be an effective, relatively well-tolerated, and safe adjunctive treatment strategy for SRI nonresponders with major depressive disorder, and our findings warrant replication
  • Patient exclusion criteria were as follows: breastfeeding women, pregnant women, or women of childbearing potential who were not using a medically accepted means of contraception; patients who demonstrated a greater than 15% decrease in depressive symptoms as reflected by the HAM–D total score between the screen and baseline visits; serious suicide or homicide risk, or unstable medical illness as assessed by an evaluating clinician; active alcohol or drug use disorder within the last 6 months; history of mania, hypomania, psychotic symptoms, or seizure disorder; clinical evidence of untreated hypothyroidism; failure to experience sufficient symptom improvement following more than four antidepressant trials during the current major depressive episode; or prior course of SAMe or intolerance to SAMe at any dose
  • The results of the present study, which is the first randomized, double-blind, placebo-controlled trial of SAMe augmentation to be conducted in this patient population, provide preliminary evidence suggesting that SAMe can be an effective, relatively well-tolerated, and safe adjunctive treatment strategy for SRI nonresponders with major depressive disorder
  • Results of studies like these serve to remind clinicians and researchers alike of the urgent need to continue to develop new as well as novel treatments for major depressive disorder

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