Effectiveness of vortioxetine in real-world clinical practice: Interim results from the relieve study
Bibliographic record
Abstract
Introduction Vortioxetine has demonstrated sustained efficacy and favorable safety profile in multiple clinical trials. Objectives This study aims to describe the effectiveness and safety of vortioxetine in real-world clinical practice. Methods RELIEVE is a prospective, multi-national, observational cohort study of outpatients initiating vortioxetine treatment for MDD at physician’s discretion and followed for 6 months. Data were collected at routine clinical visits. The primary outcome was functioning measured by Sheehan Disability Scale (SDS). Depressive symptoms measured by Patient Health Questionnaire 9-item (PHQ-9), cognitive symptoms measured by PDQ-5 and DSST were key secondary outcomes. Safety outcomes including adverse events were reported. This interim analysis presents results of 527 patients who completed the study and were followed for 6 months. Mixed models of repeated measures were used to assess improvements between baseline and month 6, adjusted for relevant confounders. Results A total of 527 patients (mean age, 50.2 years, 65% female) were enrolled from US, Canada, France and Italy, and included in the analysis. Mean SDS total score, PHQ-9, PDQ-5 scores decreased by 8.6, 7.4 and 4.7 respectively from baseline to last visit. Mean DSST score improved by 6.5 from baseline to last visit. Patients’ overall functioning and quality of life significantly improved, sick leave days and underproductive days (both absenteeism and presenteeism) decreased over the entire follow up period. The overall incidence of adverse events(AE) was 25%, with the most common AEs being nausea and headache. Conclusions The results confirm the effectiveness and good tolerability of vortioxetine in a broad range of patients in routine clinical practice. Conflict of interest Dr. Mattingly has served as researcher, consultant or speaker for Akili, Alcobra, Alkermes, Allergan, Axsome, Boehringer, Forum, Genentech, Jansen, Lundbeck, Medgenics, Merck, Neos, NLS Pharma, Otsuka, Reckitt Benckiser, Roche, Sage, Shire, Sunovion, Supe
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.008 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".