2249 – Efficacy And Safety Of 3 Agomelatine Dose Regimens (10, 25, 25-50 Mg) Versus Placebo In Out-patients Suffering From Moderate To Severe Major Depressive Disorder
Bibliographic record
Abstract
The present analysis assesses the 6-week antidepressant efficacy and safety of 3 agomelatine dose regimens of (10, 25, 25-50 mg) versus placebo in out-patients suffering from moderate to severe Major Depressive Disorder (MDD). In this phase III, multicentre, international, randomised, double-blind, placebo-controlled trial, 549 patients were randomized in four parallel groups: agomelatine 10 mg (n=133), agomelatine 25 mg (n=138), agomelatine 25 mg -50 mg (n=137) or placebo (n=141). In the 25-50 mg group, a dose up-titration in blinded conditions to 50 mg at week 2 was done if insufficient improvement. In the FAS (N=547), at last post-baseline assessment, there were significant and incremental differences (E(SE)) on mean HAM-D total score in favor of each agomelatine dose vs placebo: 10 mg - 2.46(0.76) (p=0.001); 25 mg - 4.71 (0.75) (p< 0.0001); 25-50 mg - 4.92 (0.76) (p< 0.0001). The response rate (decrease in HAM-D total score = 50% from baseline) was higher on each agomelatine group: 40.9% on 10 mg, 50.7% on 25 mg, 52.2% on 25-50 mg than on placebo (24.8%), p=0.005, p< 0.0001 and p< 0.0001 respectively. There were less study discontinuation on agomelatine 10 mg, 25 mg and 25-50 mg than on placebo (7.5%, 5.8%, 8.0% and 10.6% respectively) and few discontinuations for adverse events (0.8%, 0.7% and 0.7% respectively) vs none on placebo. The most frequent emergent adverse events on agomelatine (in at least 5% of patients in any agomelatine groups) were headache and nausea. These results demonstrate antidepressant efficacy at 3 dose regimens of agomelatine (10, 25, 25-50 mg) in MDD patients.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".