Evidence map›Paper›PMID 22687580›Full record

Trial reportThe Journal of clinical psychiatry2012

Bioavailability of S-adenosyl methionine and impact on response in a randomized, double-blind, placebo-controlled trial in major depressive disorder.

David Mischoulon, Jonathan E Alpert, Erland Arning, Teodoro Bottiglieri, Maurizio Fava, George I Papakostas

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical psychiatry, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00093847 (S-adenosyl Methionine), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00093847 phase2completednot on this map

S-adenosyl Methionine (SAMe) Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) for Treatment-Resistant Depression (TRD)

TypeinterventionalSponsorMassachusetts General HospitalRan2004 to 2009Enrolled73ConditionsDepressionArmsS-adenosyl methione (SAMe), Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. S-adenosyl methionine (SAMe) for depression in adults.The Cochrane database of systematic reviews · 2016
    Pooled it
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. S-Adenosyl Methionine and Transmethylation Pathways in Neuropsychiatric Diseases Throughout Life.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2018
    Review
  10. Article
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

David MischoulonMassachusetts General Hospital, Boston, MA 02114, USA. dmischoulon@partners.org
Jonathan E Alpert
Erland Arning
Teodoro Bottiglieri
Maurizio Fava
George I Papakostas
Harvard University Press · USBaylor University Medical Center · USMassachusetts General Hospital · US

Funding

S-Adenosyl Methionine(SAMe)Augmentation of SSRIs in MDDK23MH069629 · NIMH · MASSACHUSETTS GENERAL HOSPITAL · PI PAPAKOSTAS, GEORGE I · 2004 to 2008
$881k
Effect of S-adenosylmethionine on blood homocysteineR21AT002311 · NCCIH · BAYLOR RESEARCH INSTITUTE · PI BOTTIGLIERI, TEODORO · 2006 to 2008
$153k
NCCIH NIH HHS AT002311-01NCCIH NIH HHS R21 AT002311NIMH NIH HHS 5-K23 MH-069629NIMH NIH HHS K23 MH069629
6 · The paper itself

Abstract

objectiveTo characterize the impact of S-adenosyl methionine (SAMe) on homocysteine and potential risk of adverse cardiovascular effects by examining plasma levels of SAMe, S-adenosyl homocysteine (SAH), total homocysteine (tHCY), methionine (MET), and 5-methyltetrahydrofolate (5-MTHF) in 35 of 73 patients from a 6-week randomized double-blind, placebo-controlled trial of SAMe augmentation in serotonin reuptake inhibitor partial responders with DSM-IV major depressive disorder (MDD), published in 2010.

methodSubjects were randomized from June 4, 2004, until August 8, 2008, to adjunctive placebo or SAMe 800-1600 mg/d for 6 weeks. Primary outcome measures included changes in one-carbon cycle intermediates within each treatment arm (by paired t test) and between treatment arms (by independent samples t test). Univariate analysis of variance and Fisher Protected Least Significant Difference were carried out to compare posttreatment levels of each one-carbon cycle intermediate. Secondary outcome measures included associations between clinical improvement and change in plasma intermediate levels, examined by linear regression (for change in Hamilton Depression Rating Scale scores) and logistic regression (for response or remission).

resultsWe found significant differences in pretreatment plasma levels of tHCY (P = .03) between the SAMe and placebo arms. Following 6 weeks of treatment, plasma SAMe (P = .002) and SAH (P < .0001) levels increased significantly in the SAMe arm; no intermediates in the placebo group changed significantly. Posttreatment plasma SAMe (P = .0035), SAH (P < .0001), and tHCY (P = .0016) levels differed significantly between the SAMe and placebo groups. No significant associations were found between plasma intermediate levels and clinical improvement, response, or remission.

conclusionsDespite concerns about the impact that SAMe therapy may have on homocysteine levels and risk of adverse cardiovascular effects, the lack of significant increase in tHCY levels after treatment suggests that no toxic effects from SAMe should be expected. Our findings, however, have some significant limitations and should be interpreted with caution.

trial registrationClinicalTrials.gov identifier: NCT00093847.

Indexed as

Biological AvailabilityDietary SupplementsDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleHomocysteineHumansMajor Depressive DisorderMaleMethionineMiddle AgedPsychiatric Status Rating ScalesS-AdenosylhomocysteineS-AdenosylmethionineSelective Serotonin Reuptake Inhibitors5-methyltetrahydrofolateHomocysteineMethionineS-AdenosylhomocysteineS-AdenosylmethionineSelective Serotonin Reuptake InhibitorsTetrahydrofolates

Identifiers

PMID22687580
PMCPMC4156851
OpenAlexW2054265884

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.