PMID- 20595412 OWN - NLM STAT- MEDLINE DCOM- 20100824 LR - 20221207 IS - 1535-7228 (Electronic) IS - 0002-953X (Linking) VI - 167 IP - 8 DP - 2010 Aug TI - S-adenosyl methionine (SAMe) augmentation of serotonin reuptake inhibitors for antidepressant nonresponders with major depressive disorder: a double-blind, randomized clinical trial. PG - 942-8 LID - 10.1176/appi.ajp.2009.09081198 [doi] AB - OBJECTIVE: Despite the progressive increase in the number of antidepressants, many patients with major depressive disorder continue to be symptomatic. Clearly, there is an urgent need to develop better tolerated and more effective treatments for this disorder. The use of S-adenosyl methionine (SAMe), a naturally occurring molecule that serves as a methyl donor in human cellular metabolism, as adjunctive treatment for antidepressant nonresponders with major depressive disorder represents one such effort toward novel pharmacotherapy development. METHOD: Participants were 73 serotonin reuptake inhibitor (SRI) nonresponders with major depressive disorder enrolled in a 6-week, double-blind, randomized trial of adjunctive oral SAMe (target dose: 800 mg/twice daily). Patients continued to receive their SRI treatment at a stable dose throughout the 6-week trial. The primary outcome measure for the study was the response rates according to the 17-item Hamilton Depression Rating Scale (HAM-D). RESULTS: The HAM-D response and remission rates were higher for patients treated with adjunctive SAMe (36.1% and 25.8%, respectively) than adjunctive placebo (17.6% versus 11.7%, respectively). The number needed to treat for response and remission was approximately one in six and one in seven, respectively. There was no statistically significant difference in the proportion of SAMe- versus placebo-treated patients who discontinued the trial for any reason (20.6% versus 29.5%, respectively), due to adverse events (5.1% versus 8.8%, respectively), or due to inefficacy (5.1% versus 11.7%, respectively). CONCLUSIONS: These preliminary results suggest that SAMe can be an effective, well-tolerated, and safe adjunctive treatment strategy for SRI nonresponders with major depressive disorder and warrant replication. FAU - Papakostas, George I AU - Papakostas GI AD - Center for Treatment-Resistant Depression, Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, 15 Parkman St., Boston, MA 02114, USA. gpapakostas@partners.org FAU - Mischoulon, David AU - Mischoulon D FAU - Shyu, Irene AU - Shyu I FAU - Alpert, Jonathan E AU - Alpert JE FAU - Fava, Maurizio AU - Fava M LA - eng SI - ClinicalTrials.gov/NCT00093847 GR - 5-K23 MH-069629/MH/NIMH NIH HHS/United States PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20100701 PL - United States TA - Am J Psychiatry JT - The American journal of psychiatry JID - 0370512 RN - 0 (Antidepressive Agents) RN - 0 (Placebos) RN - 0 (Serotonin Uptake Inhibitors) RN - 0 (adenosyl-methionine 1,4-butanedisulfonate) RN - 7LP2MPO46S (S-Adenosylmethionine) SB - IM CIN - Am J Psychiatry. 2010 Aug;167(8):889-91. PMID: 20693465 CIN - Am J Psychiatry. 2010 Dec;167(12):1533; author reply 1533. PMID: 21131413 MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antidepressive Agents/*therapeutic use MH - Depressive Disorder MH - Depressive Disorder, Major/diagnosis/*drug therapy/psychology MH - Double-Blind Method MH - Drug Resistance MH - Drug Therapy, Combination MH - Female MH - Humans MH - Male MH - Middle Aged MH - Patient Dropouts MH - Placebos MH - Psychiatric Status Rating Scales/statistics & numerical data MH - S-Adenosylmethionine/*analogs & derivatives/therapeutic use MH - Selective Serotonin Reuptake Inhibitors/*therapeutic use MH - Treatment Outcome EDAT- 2010/07/03 06:00 MHDA- 2010/08/25 06:00 CRDT- 2010/07/03 06:00 PHST- 2010/07/03 06:00 [entrez] PHST- 2010/07/03 06:00 [pubmed] PHST- 2010/08/25 06:00 [medline] AID - appi.ajp.2009.09081198 [pii] AID - 10.1176/appi.ajp.2009.09081198 [doi] PST - ppublish SO - Am J Psychiatry. 2010 Aug;167(8):942-8. doi: 10.1176/appi.ajp.2009.09081198. Epub 2010 Jul 1.