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

Abstract

BACKGROUND

Depression 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/DESIGN

The 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.

CONCLUSIONS

The 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 REGISTRATION

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

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  • Authors+Show Affiliations

    ,

    Western Australian Centre for Health & Ageing, Centre for Medical Research, University of Western Australia, Perth, Australia.

    , , , , , ,

    Source

    Trials 11: 2010 Jan 25 pg 8

    MeSH

    Age Factors
    Antidepressive Agents
    Biomarkers
    Citalopram
    Depression
    Double-Blind Method
    Drug Therapy, Combination
    Folic Acid
    Homocysteine
    Humans
    Hyperhomocysteinemia
    Medication Adherence
    Middle Aged
    Psychiatric Status Rating Scales
    Research Design
    Severity of Illness Index
    Time Factors
    Treatment Outcome
    Vitamin B 12
    Vitamin B 6
    Vitamin B Complex
    Western Australia

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    20096138

    Citation

    Ford, Andrew H., et al. "The B-VITAGE Trial: a Randomized Trial of Homocysteine Lowering Treatment of Depression in Later Life." Trials, vol. 11, 2010, p. 8.
    Ford AH, Flicker L, McCaul K, et al. The B-VITAGE trial: a randomized trial of homocysteine lowering treatment of depression in later life. Trials. 2010;11:8.
    Ford, A. H., Flicker, L., McCaul, K., van Bockxmeer, F., Hegarty, S., Hirani, V., ... Almeida, O. P. (2010). The B-VITAGE trial: a randomized trial of homocysteine lowering treatment of depression in later life. Trials, 11, p. 8. doi:10.1186/1745-6215-11-8.
    Ford AH, et al. The B-VITAGE Trial: a Randomized Trial of Homocysteine Lowering Treatment of Depression in Later Life. Trials. 2010 Jan 25;11:8. PubMed PMID: 20096138.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The B-VITAGE trial: a randomized trial of homocysteine lowering treatment of depression in later life. AU - Ford,Andrew H, AU - Flicker,Leon, AU - McCaul,Kieran, AU - van Bockxmeer,Frank, AU - Hegarty,Sarah, AU - Hirani,Varsha, AU - Fenner,Stephen, AU - Almeida,Osvaldo P, Y1 - 2010/01/25/ PY - 2009/11/02/received PY - 2010/01/25/accepted PY - 2010/1/26/entrez PY - 2010/1/26/pubmed PY - 2010/5/1/medline SP - 8 EP - 8 JF - Trials JO - Trials VL - 11 N2 - BACKGROUND: Depression 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/DESIGN: The 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. CONCLUSIONS: The 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 REGISTRATION: The trial is registered with the Australian Clinical Trials Registry, trial number (())ACTRN12609000256279. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/20096138/The_B_VITAGE_trial:_a_randomized_trial_of_homocysteine_lowering_treatment_of_depression_in_later_life_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-11-8 DB - PRIME DP - Unbound Medicine ER -