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The Scientific World Journal
Volume 2013, Article ID 204649, 5 pages
http://dx.doi.org/10.1155/2013/204649
Clinical Study

S-Adenosyl-L-Methionine Augmentation in Patients with Stage II Treatment-Resistant Major Depressive Disorder: An Open Label, Fixed Dose, Single-Blind Study

1Chair of Psychiatry, Department of Neurosciences and Imaging, University “G. d’Annunzio”, 66100 Chieti, Italy
2National Health Service (NHS), Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, p.zza Italia 1, ASL 4, 64100 Teramo, Italy
3Laboratory of Molecular Psychiatry and Psychopharmacotherapeutics, Section of Psychiatry, Department of Neuroscience, University School of Medicine “Federico II”, 80131 Naples, Italy
4Hermanas Hospitalarias, FoRiPsi, Villa S. Giuseppe Hospital, 63100 Ascoli Piceno, Italy
5Institute of Psychiatry, University of Catania, 95121 Catania, Italy
6Hermanas Hospitalarias, FoRiPsi, Department of Clinical Neurosciences, Villa San Benedetto Menni, Albese con Cassano, Como, Italy
7Department of Psychiatry and Behavioral Sciences, Leonard Miller School of Medicine, University of Miami, Miami, 33124 FL, USA
8Department of Psychiatry and Neuropsychology, University of Maastricht, 6200 MD Maastricht, The Netherlands

Received 15 March 2013; Accepted 18 April 2013

Academic Editors: I. Ahmed (Ike) and S. C. Bhatia

Copyright © 2013 Domenico De Berardis et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

We investigated the efficacy of S-Adenosyl-L-Methionine (SAMe) augmentation in patients with treatment-resistant depressive disorder (TRD). Thirty-three outpatients with major depressive episode who failed to respond to at least 8 weeks of treatment with two adequate and stable doses of antidepressants were treated openly with fixed dose of SAMe (800 mg) for 8 weeks, added to existing medication. The primary outcome measure was the change from baseline in total score on Hamilton Rating Scale for Depression (HAM-D). The Clinical Global Impression of Improvement (CGI-I) was rated at the endpoint. Patients with a reduction of 50% or more on HAM-D total score and a CGI-I score of 1 or 2 at endpoint were considered responders; remission was defined as a HAM-D score ≤7. Secondary outcome measures included the Snaith-Hamilton Pleasure Scale (SHAPS) and the Sheehan Disability Scale (SDS). At 8 weeks, a significant decrease in HAM-D score was observed with response achieved by 60% of the patients and remission by 36%. Also a statistically significant reduction in SHAPS and SDS was observed. Our findings indicate that SAMe augmentation may be effective and well tolerated in stage II TRD. However, limitations of the present study must be considered and further placebo-controlled trials are needed.