PMID- 32554440
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20230913
IS  - 1468-960X (Electronic)
IS  - 1362-0347 (Print)
IS  - 1362-0347 (Linking)
VI  - 23
IP  - 3
DP  - 2020 Aug
TI  - Real-world effect of antidepressants for depressive disorder in primary care: 
      protocol of a population-based cohort study.
PG  - 122-126
LID - 10.1136/ebmental-2020-300149 [doi]
AB  - INTRODUCTION: Clinical guidelines recommend antidepressants as the first line of 
      treatment for adults with moderate-to-severe depression. Randomised trials 
      provide the best evidence on the comparative effectiveness of antidepressants for 
      depression, but are limited by a short follow-up and a highly selected 
      population. We aim to conduct a cohort study on a large database to assess 
      acceptability, efficacy, safety and tolerability of antidepressant monotherapy in 
      people with depressive disorder in primary care. METHODS AND ANALYSIS: This is a 
      protocol for a cohort study using data from the QResearch primary care research 
      database, which is the largest general practice research database in the UK. We 
      will include patients registered for at least 1 year from 1 January 1998, 
      diagnosed with a new episode of depression and on antidepressant and a comparison 
      group not on antidepressant. The exposure of interest will be treatment with 
      antidepressant medications. Our outcomes will be acceptability (treatment 
      discontinuation due to any cause), efficacy (clinical response and remission); 
      safety (adverse events (AEs) and all-cause mortality); and tolerability (dropouts 
      due to any AE) measured at 2 months, 6 months and 1 year. For each outcome, we 
      will estimate the absolute risks for all antidepressants, and relative effects 
      between antidepressants using Cox's proportion hazards models. We will calculate 
      HRs and 99.9% CIs for each outcome of interest. DISCUSSION: The main limitation 
      is the observational nature of our study, while the major strengths include the 
      large representative population contained in QResearch and the possibly high 
      generalisability.
CI  - (c) Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and 
      permissions. Published by BMJ.
FAU - De Crescenzo, Franco
AU  - De Crescenzo F
AUID- ORCID: 0000-0002-2478-7763
AD  - Department of Psychiatry, University of Oxford, Oxford, Oxfordshire, UK 
      franco.decrescenzo@psych.ox.ac.uk.
AD  - Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, Oxfordshire, UK.
FAU - Garriga, Cesar
AU  - Garriga C
AUID- ORCID: 0000-0001-7073-3611
AD  - Nuffield Department of Primary Care Health Sciences, University of Oxford, 
      Oxford, UK.
FAU - Tomlinson, Anneka
AU  - Tomlinson A
AD  - Department of Psychiatry, University of Oxford, Oxford, Oxfordshire, UK.
FAU - Coupland, Carol
AU  - Coupland C
AD  - Division of Primary Care, University of Nottingham, Nottingham, UK.
FAU - Efthimiou, Orestis
AU  - Efthimiou O
AUID- ORCID: 0000-0002-0955-7572
AD  - Institute of Social and Preventive Medicine, University of Bern, Bern, 
      Switzerland.
FAU - Fazel, Seena
AU  - Fazel S
AD  - Department of Psychiatry, University of Oxford, Oxford, Oxfordshire, UK.
FAU - Hippisley-Cox, Julia
AU  - Hippisley-Cox J
AD  - Nuffield Department of Primary Care Health Sciences, University of Oxford, 
      Oxford, UK.
FAU - Cipriani, Andrea
AU  - Cipriani A
AUID- ORCID: 0000-0001-5179-8321
AD  - Department of Psychiatry, University of Oxford, Oxford, Oxfordshire, UK.
AD  - Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, Oxfordshire, UK.
LA  - eng
GR  - RP-2017-08-ST2-006/DH_/Department of Health/United Kingdom
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Observational Study
DEP - 20200618
PL  - England
TA  - Evid Based Ment Health
JT  - Evidence-based mental health
JID - 100883413
RN  - 0 (Antidepressive Agents)
SB  - IM
MH  - Adult
MH  - Antidepressive Agents/adverse effects/*pharmacology
MH  - Clinical Protocols
MH  - Cohort Studies
MH  - Depressive Disorder/*drug therapy
MH  - Humans
MH  - Mortality
MH  - *Outcome Assessment, Health Care
MH  - *Patient Acceptance of Health Care
MH  - Patient Dropouts
MH  - Primary Health Care
MH  - Proportional Hazards Models
MH  - Remission Induction
PMC - PMC10231559
OTO - NOTNLM
OT  - adult psychiatry
OT  - depression & mood disorders
COIS- Competing interests: AC has received research and consultancy fees from INCiPiT 
      (Italian Network for Paediatric Trials) and Angelini Pharma. He has also 
      organised a workshop about digital mental health sponsored by Angelini Pharma.
EDAT- 2020/06/20 06:00
MHDA- 2021/05/15 06:00
PMCR- 2020/08/01
CRDT- 2020/06/20 06:00
PHST- 2020/06/20 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/06/20 06:00 [entrez]
PHST- 2020/08/01 00:00 [pmc-release]
AID - ebmental-2020-300149 [pii]
AID - 10.1136/ebmental-2020-300149 [doi]
PST - ppublish
SO  - Evid Based Ment Health. 2020 Aug;23(3):122-126. doi: 
      10.1136/ebmental-2020-300149. Epub 2020 Jun 18.