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

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 antidepressa...

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Main Authors: Domenico De Berardis, Stefano Marini, Nicola Serroni, Gabriella Rapini, Felice Iasevoli, Alessandro Valchera, Maria Signorelli, Eugenio Aguglia, Giampaolo Perna, Anatolia Salone, Giuseppe Di Iorio, Giovanni Martinotti, Massimo Di Giannantonio
Format: Article
Language:English
Published: Wiley 2013-01-01
Series:The Scientific World Journal
Online Access:http://dx.doi.org/10.1155/2013/204649
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author Domenico De Berardis
Stefano Marini
Nicola Serroni
Gabriella Rapini
Felice Iasevoli
Alessandro Valchera
Maria Signorelli
Eugenio Aguglia
Giampaolo Perna
Anatolia Salone
Giuseppe Di Iorio
Giovanni Martinotti
Massimo Di Giannantonio
author_facet Domenico De Berardis
Stefano Marini
Nicola Serroni
Gabriella Rapini
Felice Iasevoli
Alessandro Valchera
Maria Signorelli
Eugenio Aguglia
Giampaolo Perna
Anatolia Salone
Giuseppe Di Iorio
Giovanni Martinotti
Massimo Di Giannantonio
author_sort Domenico De Berardis
collection DOAJ
description 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.
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spelling doaj-art-91c11c8dfd724a3395d32c3e92ff89212025-02-03T01:21:17ZengWileyThe Scientific World Journal1537-744X2013-01-01201310.1155/2013/204649204649S-Adenosyl-L-Methionine Augmentation in Patients with Stage II Treatment-Resistant Major Depressive Disorder: An Open Label, Fixed Dose, Single-Blind StudyDomenico De Berardis0Stefano Marini1Nicola Serroni2Gabriella Rapini3Felice Iasevoli4Alessandro Valchera5Maria Signorelli6Eugenio Aguglia7Giampaolo Perna8Anatolia Salone9Giuseppe Di Iorio10Giovanni Martinotti11Massimo Di Giannantonio12Chair of Psychiatry, Department of Neurosciences and Imaging, University “G. d’Annunzio”, 66100 Chieti, ItalyChair of Psychiatry, Department of Neurosciences and Imaging, University “G. d’Annunzio”, 66100 Chieti, ItalyNational Health Service (NHS), Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, p.zza Italia 1, ASL 4, 64100 Teramo, ItalyNational Health Service (NHS), Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, p.zza Italia 1, ASL 4, 64100 Teramo, ItalyLaboratory of Molecular Psychiatry and Psychopharmacotherapeutics, Section of Psychiatry, Department of Neuroscience, University School of Medicine “Federico II”, 80131 Naples, ItalyHermanas Hospitalarias, FoRiPsi, Villa S. Giuseppe Hospital, 63100 Ascoli Piceno, ItalyInstitute of Psychiatry, University of Catania, 95121 Catania, ItalyInstitute of Psychiatry, University of Catania, 95121 Catania, ItalyHermanas Hospitalarias, FoRiPsi, Department of Clinical Neurosciences, Villa San Benedetto Menni, Albese con Cassano, Como, ItalyChair of Psychiatry, Department of Neurosciences and Imaging, University “G. d’Annunzio”, 66100 Chieti, ItalyChair of Psychiatry, Department of Neurosciences and Imaging, University “G. d’Annunzio”, 66100 Chieti, ItalyChair of Psychiatry, Department of Neurosciences and Imaging, University “G. d’Annunzio”, 66100 Chieti, ItalyChair of Psychiatry, Department of Neurosciences and Imaging, University “G. d’Annunzio”, 66100 Chieti, ItalyWe 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.http://dx.doi.org/10.1155/2013/204649
spellingShingle Domenico De Berardis
Stefano Marini
Nicola Serroni
Gabriella Rapini
Felice Iasevoli
Alessandro Valchera
Maria Signorelli
Eugenio Aguglia
Giampaolo Perna
Anatolia Salone
Giuseppe Di Iorio
Giovanni Martinotti
Massimo Di Giannantonio
S-Adenosyl-L-Methionine Augmentation in Patients with Stage II Treatment-Resistant Major Depressive Disorder: An Open Label, Fixed Dose, Single-Blind Study
The Scientific World Journal
title S-Adenosyl-L-Methionine Augmentation in Patients with Stage II Treatment-Resistant Major Depressive Disorder: An Open Label, Fixed Dose, Single-Blind Study
title_full S-Adenosyl-L-Methionine Augmentation in Patients with Stage II Treatment-Resistant Major Depressive Disorder: An Open Label, Fixed Dose, Single-Blind Study
title_fullStr S-Adenosyl-L-Methionine Augmentation in Patients with Stage II Treatment-Resistant Major Depressive Disorder: An Open Label, Fixed Dose, Single-Blind Study
title_full_unstemmed S-Adenosyl-L-Methionine Augmentation in Patients with Stage II Treatment-Resistant Major Depressive Disorder: An Open Label, Fixed Dose, Single-Blind Study
title_short S-Adenosyl-L-Methionine Augmentation in Patients with Stage II Treatment-Resistant Major Depressive Disorder: An Open Label, Fixed Dose, Single-Blind Study
title_sort s adenosyl l methionine augmentation in patients with stage ii treatment resistant major depressive disorder an open label fixed dose single blind study
url http://dx.doi.org/10.1155/2013/204649
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