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      Youth Depression Alleviation with Anti-inflammatory Agents (YoDA-A): a randomised clinical trial of rosuvastatin and aspirin

      , 1 , 2 , 3 , 4 , 5 , 6 , 3 , 7 , 3 , 4 , 6 , 1 , 2 , 1 , 2 , 8 , 2 , 3 , 5 , 6 , 1 , 2 , 8 , 1 , 2 , 1 , 2 , 8 , 1 , 2 , 9 , 10 , 5 , 8 , 1 , 2 , 1 , 2 , 1 , 2 , 1 , 2 , 1 , 2 , 8 , 1 , 2 , 1 , 2 , 8 , 2 , 11 , 1 , 2 , 10 , 12 , 1 , 2 , 3 , 1 , 2 , 1 , 2 , 8

      BMC Medicine

      BioMed Central

      Depression, Treatment, Statins

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          Abstract

          Background

          Inflammation contributes to the pathophysiology of major depressive disorder (MDD), and anti-inflammatory strategies might therefore have therapeutic potential. This trial aimed to determine whether adjunctive aspirin or rosuvastatin, compared with placebo, reduced depressive symptoms in young people (15–25 years).

          Methods

          YoDA-A, Youth Depression Alleviation with Anti-inflammatory Agents, was a 12-week triple-blind, randomised, controlled trial. Participants were young people (aged 15–25 years) with moderate to severe MDD (MADRS mean at baseline 32.5 ± 6.0; N = 130; age 20.2 ± 2.6; 60% female), recruited between June 2013 and June 2017 across six sites in Victoria, Australia. In addition to treatment as usual, participants were randomised to receive aspirin ( n = 40), rosuvastatin ( n = 48), or placebo ( n = 42), with assessments at baseline and weeks 4, 8, 12, and 26. The primary outcome was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 12.

          Results

          At the a priori primary endpoint of MADRS differential change from baseline at week 12, there was no significant difference between aspirin and placebo (1.9, 95% CI (− 2.8, 6.6), p = 0.433), or rosuvastatin and placebo (− 4.2, 95% CI (− 9.1, 0.6), p = 0.089). For rosuvastatin, secondary outcomes on self-rated depression and global impression, quality of life, functioning, and mania were not significantly different from placebo. Aspirin was inferior to placebo on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) at week 12. Statins were superior to aspirin on the MADRS, the Clinical Global Impressions Severity Scale (CGI-S), and the Negative Problem Orientation Questionnaire scale (NPOQ) at week 12.

          Conclusions

          The addition of either aspirin or rosuvastatin did not to confer any beneficial effect over and above routine treatment for depression in young people. Exploratory comparisons of secondary outcomes provide limited support for a potential therapeutic role for adjunctive rosuvastatin, but not for aspirin, in youth depression.

          Trial registration

          Australian New Zealand Clinical Trials Registry, ACTRN12613000112763. Registered on 30/01/2013.

          Related collections

          Most cited references 49

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          To GEE or not to GEE: comparing population average and mixed models for estimating the associations between neighborhood risk factors and health.

          Two modeling approaches are commonly used to estimate the associations between neighborhood characteristics and individual-level health outcomes in multilevel studies (subjects within neighborhoods). Random effects models (or mixed models) use maximum likelihood estimation. Population average models typically use a generalized estimating equation (GEE) approach. These methods are used in place of basic regression approaches because the health of residents in the same neighborhood may be correlated, thus violating independence assumptions made by traditional regression procedures. This violation is particularly relevant to estimates of the variability of estimates. Though the literature appears to favor the mixed-model approach, little theoretical guidance has been offered to justify this choice. In this paper, we review the assumptions behind the estimates and inference provided by these 2 approaches. We propose a perspective that treats regression models for what they are in most circumstances: reasonable approximations of some true underlying relationship. We argue in general that mixed models involve unverifiable assumptions on the data-generating distribution, which lead to potentially misleading estimates and biased inference. We conclude that the estimation-equation approach of population average models provides a more useful approximation of the truth.
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            Major depressive disorder in older adolescentsPrevalence, risk factors, and clinical implications

             P LEWINSOHN (1998)
            In this article we summarize our current understanding of depression in older (14-18 years old) adolescents based on our program of research (the Oregon Adolescent Depression Project). Specifically, we address the following factors regarding adolescent depression: (a) phenomenology (e.g., occurrence of specific symptoms, gender and age effects, community versus clinic samples); (b) epidemiology (e.g., prevalence, incidence, duration, onset age); (c) comorbidity with other mental and physical disorders; (d) psychosocial characteristics associated with being, becoming, and having been depressed; (e) recommended methods of assessment and screening; and (f) the efficacy of a treatment intervention developed for adolescent depression, the Adolescent Coping With Depression course. We conclude by providing a set of summary statements and recommendations for clinicians.
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              Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure.

              The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The summary scores were found to be reliable and valid measures of these dimensions in a group of depressed outpatients. The Q-LES-Q measures were related to, but not redundant with, measures of overall severity of illness or severity of depression within this sample. These findings suggest that the Q-LES-Q measures may be sensitive to important differences among depressed patients that are not detected by the measures usually employed.
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                Author and article information

                Contributors
                michael.berk@deakin.edu.au
                Journal
                BMC Med
                BMC Med
                BMC Medicine
                BioMed Central (London )
                1741-7015
                17 January 2020
                17 January 2020
                2020
                : 18
                Affiliations
                [1 ]GRID grid.488501.0, Orygen, the National Centre of Excellence in Youth Mental Health, ; Melbourne, Australia
                [2 ]ISNI 0000 0001 2179 088X, GRID grid.1008.9, Centre for Youth Mental Health, , University of Melbourne, ; Parkville, Australia
                [3 ]ISNI 0000 0001 0526 7079, GRID grid.1021.2, The Institute for Mental and Physical Health and Clinical Translation, , Deakin University, ; Geelong, Australia
                [4 ]ISNI 0000 0001 2179 088X, GRID grid.1008.9, Florey Institute for Neuroscience and Mental Health, , University of Melbourne, ; Parkville, Australia
                [5 ]ISNI 0000 0001 2179 088X, GRID grid.1008.9, Department of Psychiatry, , University of Melbourne, ; Parkville, Australia
                [6 ]ISNI 0000 0004 0540 0062, GRID grid.414257.1, Barwon Health, ; PO Box 281, Geelong, Victoria 3220 Australia
                [7 ]ISNI 0000 0001 0526 7079, GRID grid.1021.2, Biostatistics Unit, Faculty of Health, , Deakin University, ; Geelong, Australia
                [8 ]Orygen Youth Health, Northwestern Mental Health, Melbourne, Australia
                [9 ]ISNI 0000 0004 4902 0432, GRID grid.1005.4, Black Dog Institute, , University of New South Wales, ; Sydney, Australia
                [10 ]ISNI 0000 0001 2179 088X, GRID grid.1008.9, Melbourne School of Population and Global Health, , University of Melbourne, ; Melbourne, Australia
                [11 ]ISNI 0000 0004 0372 3343, GRID grid.9654.e, Department of Psychological Medicine, , University of Auckland, ; Auckland, New Zealand
                [12 ]ISNI 0000 0004 1936 7857, GRID grid.1002.3, Department of Social Work, , Monash University, ; Melbourne, Australia
                Article
                1475
                10.1186/s12916-019-1475-6
                6966789
                31948461
                © The Author(s). 2020

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000925, National Health and Medical Research Council;
                Award ID: APP1027315
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2020

                Medicine

                depression, treatment, statins

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