ArticleInternational journal of general medicine2015
Preliminary results of a randomized controlled trial carried out with a fixed combination of S-adenosyl-L-methionine and betaine versus amitriptyline in patients with mild depression.
Article in International journal of general medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 12 citations in OpenAlex.
- Pooled it
- Pooled it
- S-adenosyl methionine (SAMe) for depression in adults.The Cochrane database of systematic reviews · 2016Pooled it
- Betaine: A Promising Natural Product for Neurological and Psychiatric Diseases.Current neuropharmacology · 2026Review
- Betaine, a Potential Therapeutic Alternative for the Treatment of Depression.Current drug targets · 2025Review
- Untargeted Plasma Metabolomic Profiling in Patients with Depressive Disorders: A Preliminary Study.Metabolites · 2024Article
- Depression-associated gut microbes, metabolites and clinical trials.Frontiers in microbiology · 2024Review
- The major biogenic amine metabolites in mood disorders.Frontiers in psychiatry · 2024Review
- Discovery of the Potential Novel Pharmacodynamic Substances From Zhi-Zi-Hou-Po Decoction Based on the Concept of Co-Decoction Reaction and Analysis Strategy.Frontiers in pharmacology · 2021Article
- Gut microbial metabolites in depression: understanding the biochemical mechanisms.Microbial cell (Graz, Austria) · 2019Review
- Maternal choline status during pregnancy, but not that of betaine, is related to antenatal mental well-being: The growing up in Singapore toward healthy outcomes cohort.Depression and anxiety · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundS-adenosyl-L-methionine (SAMe), a safe, endogenous, pleiotropic methyl donor well known for its antidepressant role, has been assumed to have a possible role in increasing plasma levels of compounds known to be able to raise cardiovascular risk. Although the issue is still being debated, betaine (trimethylglycine), a specific methyl donor involved in the homocysteine circuit, may be able to reduce such a risk and/or, by determining a sparing effect on endogenous SAMe, may be able to improve the clinical efficiency of SAMe itself. Indeed, preliminary results have shown clinical improvement determined by an add-on therapy with betaine administered along with SAMe, versus SAMe alone, to patients affected by mild/moderate depression.
aimTo evaluate the safety and antidepressant role played by the association of SAMe plus betaine versus amitriptyline administered in untreated individuals with a recent diagnosis of mild depression.
methodsThis small, open-label, randomized, observational study enrolled 64 individuals with a diagnosis of mild depression according to the Zung Self-Rating Depression Scale. After randomization, they were treated with either Laroxyl(®) (amitriptyline, 75 mg/day) or DDM Metile(®) (enteric-coated SAMe, 500 mg/day, plus betaine, 250 mg/day) for 12 months. Assessment of clinical scores and tolerability was performed at T=0 and after 3, 6, and 12 months.
resultsAfter 3 months, both treatments showed a small and not statistically significant improvement. After 6 and 12 months, both treated groups demonstrated a more noticeable improved response, although the group treated with SAMe plus betaine showed better results in terms of score, number of individuals in remission, and side effects. Compliance was overlapping in both treatments.
conclusionThe association of SAMe plus betaine seems to be a safe and effective tool to counteract mild depression and also when used as monotherapy in subjects with a recent diagnosis.
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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.