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)
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 progn...
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BMC
2017-06-01
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| Series: | BMC Psychiatry |
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| Online Access: | http://link.springer.com/article/10.1186/s12888-017-1393-0 |
| _version_ | 1818013026390900736 |
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| author | L. Marwood R. Taylor K. Goldsmith R. Romeo R. Holland A. Pickles J. Hutchinson D. Dietch A. Cipriani R. Nair M.-J. Attenburrow A. H. Young J. Geddes R. H. McAllister-Williams A. J. Cleare |
| author_facet | L. Marwood R. Taylor K. Goldsmith R. Romeo R. Holland A. Pickles J. Hutchinson D. Dietch A. Cipriani R. Nair M.-J. Attenburrow A. H. Young J. Geddes R. H. McAllister-Williams A. J. Cleare |
| author_sort | L. Marwood |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-14T06:28:11Z |
| format | Article |
| id | doaj.art-a750710ba1b645078f08c6e7590650b4 |
| institution | Directory Open Access Journal |
| issn | 1471-244X |
| language | English |
| last_indexed | 2024-04-14T06:28:11Z |
| publishDate | 2017-06-01 |
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| series | BMC Psychiatry |
| spelling | doaj.art-a750710ba1b645078f08c6e7590650b42022-12-22T02:07:43ZengBMCBMC Psychiatry1471-244X2017-06-0117111210.1186/s12888-017-1393-0Study protocol for a randomised pragmatic trial comparing the clinical and cost effectiveness of lithium and quetiapine augmentation in treatment resistant depression (the LQD study)L. Marwood0R. Taylor1K. Goldsmith2R. Romeo3R. Holland4A. Pickles5J. Hutchinson6D. Dietch7A. Cipriani8R. Nair9M.-J. Attenburrow10A. H. Young11J. Geddes12R. H. McAllister-Williams13A. J. Cleare14Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonCentre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonBiostatistics & Health Informatics Department, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonHealth Services and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonBiostatistics & Health Informatics Department, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonBiostatistics & Health Informatics Department, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonNorthumberland, Tyne and Wear NHS Foundation TrustLonsdale Medical CentreDepartment of Psychiatry, University of OxfordTees, Esk and Wear Valleys NHS Foundation TrustDepartment of Psychiatry, University of OxfordCentre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonDepartment of Psychiatry, University of OxfordNorthumberland, Tyne and Wear NHS Foundation TrustCentre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonAbstract 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.http://link.springer.com/article/10.1186/s12888-017-1393-0Treatment resistant depressionLithiumQuetiapinePragmaticRandomised clinical trialLongitudinal |
| spellingShingle | L. Marwood R. Taylor K. Goldsmith R. Romeo R. Holland A. Pickles J. Hutchinson D. Dietch A. Cipriani R. Nair M.-J. Attenburrow A. H. Young J. Geddes R. H. McAllister-Williams A. J. Cleare 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) BMC Psychiatry Treatment resistant depression Lithium Quetiapine Pragmatic Randomised clinical trial Longitudinal |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Treatment resistant depression Lithium Quetiapine Pragmatic Randomised clinical trial Longitudinal |
| url | http://link.springer.com/article/10.1186/s12888-017-1393-0 |
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