Key result
Study protocol outlines planned evaluation of antidepressant safety and major adverse events in younger adults.
Why the study?
Relatively little is known about the relative safety of different classes of antidepressant drugs, particularly with long term use in adults under 65 with depression.
What are the relative and absolute risks of pre-defined adverse events comparing different classes of antidepressant drugs in adults aged under 65 years diagnosed with depression?
Cohort
Yes
What are the relative and absolute risks of pre-defined adverse events comparing different classes of antidepressant drugs in adults aged under 65 years diagnosed with depression?
This study protocol outlines a large cohort study to evaluate the relative safety and risks of different antidepressant classes in adults under 65 with depression.
BACKGROUND: Antidepressants are among the most commonly prescribed drugs in primary care in England and their use is increasing. This is largely due to longer durations of treatment of depression. Observational studies have shown some differences in adverse outcomes associated with different antidepressant drugs but relatively little is known about their relative safety particularly with long term use. The primary aim of this study is to determine the relative and absolute risks of pre-defined adverse events comparing different classes of antidepressant drugs in adults aged under 65 years and diagnosed with depression. METHODS/DESIGN: The study will identify a cohort of patients with a first recorded diagnosis of depression between 1/1/2000 and 31/07/2011, and made between the ages of 20 to 64 years using a large primary care database (QResearch). Patients will be followed up until 1/08/2012. Details of all prescriptions for antidepressants in patients in the cohort will be extracted, including the date of each prescription, the type of antidepressant drug, the dose and total quantity prescribed. Prospectively recorded data will be used to ascertain information on adverse outcomes that occurred during follow-up and after entry into the cohort. These are: all-cause mortality, suicide, attempted suicide/self-harm, sudden death, antidepressant overdose/poisoning, myocardial infarction, stroke/transient ischaemic attack, cardiac arrhythmia, epilepsy/seizures, upper gastrointestinal bleeding, falls, fractures, adverse drug reactions and motor vehicle crashes. Cox proportional hazard models will be used to estimate the association of the outcomes with class of antidepressant drug adjusting for potential confounding variables. The analyses will also examine associations by duration and dose and with the most frequently prescribed individual antidepressant drugs. Self-controlled case series analyses will be used to estimate the relative incidence of the outcomes of interest for defined time periods of antidepressant use. DISCUSSION: The results of this study will help to establish the relative safety and balance of risks for different antidepressant drugs in people aged under 65.
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Coupland et al. (2013) conducted a cohort in Depression. Antidepressant drugs vs. No current treatment was evaluated on Relative and absolute risks of pre-defined adverse events (including mortality, suicide, myocardial infarction, stroke, and others). Antidepressant safety and risks of adverse events in adults aged under 65 with depression are the focus of this study protocol, which does not yet report clinical results.
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