A randomised controlled trial assessing the severity and duration of depressive symptoms associated with a clinically significant response to sertraline versus placebo, in people presenting to primary care with depression (PANDA trial): study protocol for a randomised controlled trial

Salaminios, G. et al. (2017) A randomised controlled trial assessing the severity and duration of depressive symptoms associated with a clinically significant response to sertraline versus placebo, in people presenting to primary care with depression (PANDA trial): study protocol for a randomised controlled trial. Trials, 18, 496. (doi: 10.1186/s13063-017-2253-4) (PMID:29065916) (PMCID:PMC5655852)

Abstract

Background: Depressive symptoms are usually managed within primary care and antidepressant medication constitutes the first-line treatment. It remains unclear at present which people are more likely to benefit from antidepressant medication. This paper describes the protocol for a randomised controlled trial (PANDA) to investigate the severity and duration of depressive symptoms that are associated with a clinically significant response to sertraline compared to placebo, in people presenting to primary care with depression. Methods/design: PANDA is a randomised, double blind, placebo controlled trial in which participants are individually randomised to sertraline or placebo. Eligible participants are those who are between the ages of 18 to 74; have presented to primary care with depression or low mood during the past 2 years; have not received antidepressant or anti-anxiety medication in the 8 weeks prior to enrolment in the trial and there is clinical equipoise about the benefits of selective serotonin reuptake inhibitor (SSRI) medication. Participants who consent to participate in the trial are randomised to receive either sertraline or matching placebo, starting at 50 mg daily for 1 week, increasing to 100 mg daily for up to 11 weeks (with the option of increasing to 150 mg if required). Participants, general practitioners (GPs) and the research team will be blind to treatment allocation. The primary outcome will be depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) at 6 weeks post randomisation, measured as a continuous outcome. Secondary outcomes include depressive symptoms measured with the PHQ-9 at 2 and 12 weeks as a continuous outcome and at 2, 6 and 12 weeks as a binary outcome; follow-up scores on depressive symptoms measured with the Beck Depression Inventory-II, anxiety symptoms measured by the Generalized Anxiety Disorder-7 and quality of life measured with the Euroqol-5D-5L and Short Form-12; emotional processing task scores measured at baseline, 2 and 6 weeks; and costs associated with healthcare use, time off work and personal costs. Discussion: The PANDA trial uses a simple self-administered measure to establish the severity and duration of depressive symptoms associated with a clinically significant response to sertraline. The evidence from the trial will inform primary care prescribing practice by identifying which patients are more likely to benefit from antidepressants. Trial registration: Controlled Trials ISRCTN Registry, ISRCTN84544741. Registered on 20 March 2014. EudraCT Number: 2013-003440-22; Protocol Number: 13/0413 (version 6.1).

• Item Type: Articles
• Additional Information: The study is funded by the NIHR. The PANDA trial is independent research commissioned by the NIHR Programme Grant for Applied Research (RP-PG0610-10048).
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Robinson, Professor Jude
• Authors: Salaminios, G., Duffy, L., Ades, A., Araya, R., Button, K. S., Churchill, R., Croudace, T., Derrick, C., Dixon, P., Dowrick, C., Gilbody, S., Hollingworth, W., Jones, V., Kendrick, T., Kessler, D., Kounali, D., Lanham, P., Malpass, A., Peters, T. J., Riozzie, D., Robinson, J., Sharp, D., Thomas, L., Welton, N. J., Wiles, N., and Lewis, G.
• College/School: College of Social Sciences
• Journal Name: Trials
• Publisher: BioMed Central
• ISSN: 1745-6215
• ISSN (Online): 1745-6215
• Copyright Holders: Copyright © 2017 The Authors
• First Published: First published in Trials 18: 496
• Publisher Policy: Reproduced under a Creative Commons License