Evidence map›Paper›PMID 31733455›Full record

Trial reportJournal of affective disorders2020

Dose increase of S-Adenosyl-Methionine and escitalopram in a randomized clinical trial for major depressive disorder.

Hitoshi Sakurai, Linda L Carpenter, Audrey R Tyrka, Lawrence H Price, George I Papakostas, Christina M Dording, Albert S Yeung, Cristina Cusin, Elizabeth Ludington, Richard Bernard-Negron and 2 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of affective disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 18% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Annals of general psychiatry · 2020
    Review
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

12 authors at 4 institutions in 2 countries.

Hitoshi SakuraiDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
Linda L CarpenterButler Hospital, Department of Psychiatry and Human Behavior, Brown University School of Medicine, Providence, RI, USA.
Audrey R TyrkaButler Hospital, Department of Psychiatry and Human Behavior, Brown University School of Medicine, Providence, RI, USA.
Lawrence H PriceButler Hospital, Department of Psychiatry and Human Behavior, Brown University School of Medicine, Providence, RI, USA.
George I PapakostasDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
Christina M DordingDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
Albert S YeungDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
Cristina CusinDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
Elizabeth LudingtonAgility Clinical, Carlsbad, CA, USA.
Richard Bernard-NegronDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
Maurizio FavaDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
David MischoulonDepression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA. Electronic address: DMISCHOULON@mgh.harvard.edu.
Massachusetts General Hospital · USButler Hospital · USBrown University · USKeio University · JP

Funding

Placebo-Controlled Study of SAMe vs.Escitalopram in MDDR01AT001638 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI FAVA, MAURIZIO · 2004 to 2008
$2.8M
NCCIH NIH HHS R01 AT001638
6 · The paper itself

Abstract

backgroundThe optimal dose of S-adenosyl methionine (SAMe) for major depressive disorder (MDD) remains unclear. The objective of this analysis was to address whether a dose increase provided further improvement in cases of insufficient response using data from an existing randomized clinical trial.

methodsSixty-five patients with MDD who failed to respond to SAMe 1,600 mg/day, escitalopram 10 mg/day, or placebo for 6 weeks were treated with doubled doses of the allocated treatments for the following 6 weeks. Changes in 17-item Hamilton Depression Rating Scale, Inventory of Depressive Symptomatology-Self Rated, and Systematic Assessment for Treatment Emergent Events-Specific Inquiry were compared between the lower and higher dose treatments in each treatment group and among the higher dose treatments of SAMe, escitalopram, and placebo.

resultsVarious depression severity scores decreased significantly for all three treatment arms during the higher dose treatment. No within-group and between-group differences were found in any of the efficacy measures when comparing the doses and treatments. There was a significant difference in reported abdominal discomfort among patients receiving the higher dose of SAMe (31.3%), compared to escitalopram (8.7%) and placebo (3.8%) (χ2=7.32, p = 0.026). LIMITATIONS: The sample size was relatively small. The study duration for dose increase was relatively short.

conclusionsPatients with MDD failing to respond to 1,600 mg/day of SAMe may improve after increasing the dose to 3,200 mg/day, but we cannot rule out the contribution of a placebo effect and time-related improvement. The risk of abdominal discomfort may be increased with higher doses of SAMe.

Indexed as

AdultAntidepressive AgentsCitalopramDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMajor Depressive DisorderMaleMiddle AgedS-AdenosylmethionineTreatment OutcomeAntidepressive AgentsCitalopramS-AdenosylmethionineDose escalationEscitalopramMajor depressive disorderS-adenosyl methionine, SAMe

Identifiers

PMID31733455
PMCPMC6917851
OpenAlexW2982571585

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.