Background Non-serious adverse events (NSAEs) should be captured and reported because they can have a significant negative impact on patients and treatment adherence. However, the reporting of NSAEs in randomised controlled trials (RCTs) is limited.
Objective To identify the most important NSAEs of antidepressants for patients and clinicians, to be evaluated in RCTs and meta-analyses.
Methods We conducted online international surveys in English, German and French, including (1) adults prescribed an antidepressant for a depressive episode and (2) healthcare professionals (HCPs) prescribing antidepressants. Participants ranked the 30 most frequent NSAEs reported in the scientific literature. We fitted logit models for sets of ranked items and calculated for each AE the probability to be ranked higher than the least important AE. We also identified additional patient-important AEs not included in the ranking task via open-ended questions.
Findings We included 1631 patients from 44 different countries (1290 (79.1%) women, mean age 39.4 (SD 13), 289 (37.1%) with severe depression (PHQ-9 score =20)) and 281 HCPs (224 (79.7%) psychiatrists). The most important NSAEs for patients were insomnia (95.9%, 95% CI 95.2% to 96.5%), anxiety (95.2%, 95% CI 94.3% to 95.9%) and fatigue (94.6%, 95% CI 93.6% to 95.4%). The most important NSAEs for HCPs were sexual dysfunction (99.2%, 95% CI 98.5% to 99.6%), weight gain (98.9%, 95% CI 97.7% to 99.4%) and erectile problems (98.8%, 95% CI 97.7% to 99.4%). Participants reported 66 additional NSAEs, including emotional numbing (8.6%), trouble with concentration (7.6%) and irritability (6%).
Conclusions These most important NSAEs should be systematically reported in antidepressant trials.
Clinical implications The most important NSAEs should contribute to the core outcome set for harms in depression
To identify the most important NSAEs of antidepressants for patients and clinicians, to be evaluated in RCTs and meta-analyses.
ContributorsAstrid Chevance, Anneka Tomlinson, Philippe Ravaud, Suzanne Touboul, Catherine Henshall Viet-Thi Tran, Andrea Cipriani
Disease Category: Mental health
Disease Name: Depression
Age Range: 18
Sex: Either
Nature of Intervention: Drug
- Clinical experts
- Consumers (patients)
- Patient perspectives
- Survey
An online survey (available in English, German and French) was conducted, asking patients and HCPs to rank the NSAEs according to their perceived importance. logit models were used for sets of ranked items to obtain a general ranking of the AEs from the survey data