Evidence map›Paper›PMID 20096138›Full record

Trial reportTrials2010

The B-VITAGE trial: a randomized trial of homocysteine lowering treatment of depression in later life.

Andrew H Ford, Leon Flicker, Kieran McCaul, Frank van Bockxmeer, Sarah Hegarty, Varsha Hirani, Stephen Fenner, Osvaldo P Almeida

Erratum issuedOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Citalopram versus other anti-depressive agents for depression.The Cochrane database of systematic reviews · 2012
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Andrew H FordWestern Australian Centre for Health & Ageing, Centre for Medical Research, University of Western Australia, Perth, Australia.
Leon Flicker
Kieran McCaul
Frank van Bockxmeer
Sarah Hegarty
Varsha Hirani
Stephen Fenner
Osvaldo P Almeida
University of Western Australia · AURoyal Perth Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDepression is a leading cause of disability worldwide and depressive symptoms are common in later life. Observational evidence suggests that depression is more prevalent among people with high plasma homocysteine (tHcy), but the results of randomized trials to date have been unable to show that lowering tHcy through the supplementation of vitamins B6, B12 and folate benefits depressive symptoms. We designed the B-VITAGE trial to determine whether adjunctive treatment with vitamins B6, B12 and folate increases the efficacy of standard antidepressant treatment. METHODS/

designThe B-VITAGE trial is a 12-month randomized, double-blind, placebo-controlled trial of daily citalopram (20 to 40 mg) plus B12(0.5 mg), B6 (25 mg) and folic acid (2 mg) or citalopram (20 to 40 mg) plus placebo for the treatment of depression in later life. The trial aims to recruit over 300 older adults with major depression (DSM-IV) and has been powered to detect the impact of an intervention associated with moderate effect size. Depressive symptoms will be rated with the Montgomery-Asberg Depression Rating Scale (MADRS). The trial has two main outcomes of interest: a reduction of 50% or more in the MADRS total score between baseline and week 12 and the remission of the depressive episode at weeks 12, 26 and 52 according to DSM-IV criteria. We hypothesize that subjects randomly allocated to the vitamin arm of the study will be more likely to show a clinically significant improvement and achieve and maintain remission of symptoms at 12, 26 and 52 weeks. Secondary outcomes of interest include compliance with treatment, reduction in the severity of depressive symptoms, switching to different antidepressants, the use of non-pharmacological antidepressant treatments, response to treatment according to MTHFRC677T genotype, and changes in cognitive function over 52 weeks.

conclusionsThe results of this trial will clarify whether the systematic use of B-vitamins improves the response of older adults to standard antidepressant treatment. We anticipate that our findings will have implications for clinical practice and health policy development.

trial registrationThe trial is registered with the Australian Clinical Trials Registry, trial number (())ACTRN12609000256279.

Indexed as

Age FactorsAntidepressive AgentsBiomarkersCitalopramDepressionDouble-Blind MethodDrug Therapy, CombinationFolic AcidHomocysteineHumansHyperhomocysteinemiaMedication AdherenceMiddle AgedPsychiatric Status Rating ScalesResearch DesignSeverity of Illness IndexAntidepressive AgentsBiomarkersCitalopramFolic AcidHomocysteineVitamin B 12Vitamin B 6Vitamin B Complex

Identifiers

PMID20096138
PMCPMC2822769
OpenAlexW2121047084

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.