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      Study protocol for a randomised pragmatic trial comparing the clinical and cost effectiveness of lithium and quetiapine augmentation in treatment resistant depression (the LQD study)

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          Abstract

          Background

          Approximately 30–50% of patients with major depressive disorder can be classed as treatment resistant, widely defined as a failure to respond to two or more adequate trials of antidepressants in the current episode. Treatment resistant depression is associated with a poorer prognosis and higher mortality rates. One treatment option is to augment an existing antidepressant with a second agent. Lithium and the atypical antipsychotic quetiapine are two such add-on therapies and are currently recommended as first line options for treatment resistant depression. However, whilst neither treatment has been established as superior to the other in short-term studies, they have yet to be compared head-to-head in longer term studies, or with a superiority design in this patient group.

          Methods

          The Lithium versus Quetiapine in Depression ( LQD) study is a parallel group, multi-centre, pragmatic, open-label, patient randomised clinical trial designed to address this gap in knowledge. The study will compare the clinical and cost effectiveness of the decision to prescribe lithium or quetiapine add-on therapy to antidepressant medication for patients with treatment resistant depression. Patients will be randomised 1:1 and followed up over 12 months, with the hypothesis being that quetiapine will be superior to lithium. The primary outcomes will be: (1) time to all-cause treatment discontinuation over one year, and (2) self-rated depression symptoms rated weekly for one year via the Quick Inventory of Depressive Symptomatology. Other outcomes will include between group differences in response and remission rates, quality of life, social functioning, cost-effectiveness and the frequency of serious adverse events and side effects.

          Discussion

          The trial aims to help shape the treatment pathway for patients with treatment resistant depression, by determining whether the decision to prescribe quetiapine is superior to lithium. Strengths of the study include its pragmatic superiority design, broad inclusion criteria (external validity) and longer follow up than previous studies.

          Trial registration

          ISRCTN registry: ISRCTN16387615, registered 28 February 2016. ClinicalTrials.gov: NCT03004521, registered 17 November 2016.

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          Most cited references26

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          Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing

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            The Inventory of Depressive Symptomatology (IDS): psychometric properties.

            The psychometric properties of the 28- and 30-item versions of the Inventory of Depressive Symptomatology, Clinician-Rated (IDS-C) and Self-Report (IDS-SR) are reported in a total of 434 (28-item) and 337 (30-item) adult out-patients with current major depressive disorder and 118 adult euthymic subjects (15 remitted depressed and 103 normal controls). Cronbach's alpha ranged from 0.92 to 0.94 for the total sample and from 0.76 to 0.82 for those with current depression. Item total correlations, as well as several tests of concurrent and discriminant validity are reported. Factor analysis revealed three dimensions (cognitive/mood, anxiety/arousal and vegetative) for each scale. Analysis of sensitivity to change in symptom severity in an open-label trial of fluoxetine (N = 58) showed that the IDS-C and IDS-SR were highly related to the 17-item Hamilton Rating Scale for Depression. Given the more complete item coverage, satisfactory psychometric properties, and high correlations with the above standard ratings, the 30-item IDS-C and IDS-SR can be used to evaluate depressive symptom severity. The availability of similar item content for clinician-rated and self-reported versions allows more direct evaluations of these two perspectives.
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              The PRECIS-2 tool: designing trials that are fit for purpose.

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                Author and article information

                Contributors
                lindsey.marwood@kcl.ac.uk
                rachael.taylor@kcl.ac.uk
                kimberley.goldsmith@kcl.ac.uk
                renee.romeo@kcl.ac.uk
                rachel.holland@kcl.ac.uk
                andrew.pickles@kcl.ac.uk
                jake.hutchinson@ntw.nhs.uk
                ddietch@nhs.net
                andrea.cipriani@psych.ox.ac.uk
                rajesh.nair1@nhs.net
                mary-jane.attenburrow@psych.ox.ac.uk
                allan.young@kcl.ac.uk
                john.geddes@psych.ox.ac.uk
                Hamish.mcallister-williams@newcastle.ac.uk
                anthony.cleare@kcl.ac.uk
                Journal
                BMC Psychiatry
                BMC Psychiatry
                BMC Psychiatry
                BioMed Central (London )
                1471-244X
                26 June 2017
                26 June 2017
                2017
                : 17
                : 231
                Affiliations
                [1 ]ISNI 0000 0001 2322 6764, GRID grid.13097.3c, Centre for Affective Disorders, Department of Psychological Medicine, , Institute of Psychiatry, Psychology & Neuroscience, King’s College London, ; London, UK
                [2 ]ISNI 0000 0000 9439 0839, GRID grid.37640.36, , South London and Maudsley NHS Foundation Trust, ; London, UK
                [3 ]ISNI 0000 0001 2322 6764, GRID grid.13097.3c, Biostatistics & Health Informatics Department, , Institute of Psychiatry, Psychology & Neuroscience, King’s College London, ; London, UK
                [4 ]ISNI 0000 0001 2322 6764, GRID grid.13097.3c, Health Services and Population Research, , Institute of Psychiatry, Psychology & Neuroscience, King’s College London, ; London, UK
                [5 ]GRID grid.451089.1, , Northumberland, Tyne and Wear NHS Foundation Trust, ; Newcastle upon Tyne, UK
                [6 ]ISNI 0000 0001 0462 7212, GRID grid.1006.7, , Institute of Neuroscience, Newcastle University, ; Newcastle upon Tyne, UK
                [7 ]Lonsdale Medical Centre, London, UK
                [8 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Department of Psychiatry, , University of Oxford, ; Oxford, UK
                [9 ]ISNI 0000 0004 0573 576X, GRID grid.451190.8, , Oxford Health NHS Foundation Trust, ; Oxford, UK
                [10 ]GRID grid.439606.e, , Tees, Esk and Wear Valleys NHS Foundation Trust, ; Darlington, UK
                Author information
                http://orcid.org/0000-0002-5818-2199
                Article
                1393
                10.1186/s12888-017-1393-0
                5485607
                28651526
                2b57bda5-7eb6-46e3-b474-a5160b88c808
                © The Author(s). 2017

                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.

                History
                : 9 June 2017
                : 21 June 2017
                Funding
                Funded by: Health Technology Assessment Programme (GB)
                Award ID: 14/222/02
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2017

                Clinical Psychology & Psychiatry
                treatment resistant depression,lithium,quetiapine,pragmatic,randomised clinical trial,longitudinal,open-label,multi-centre,augmentation,superiority design

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