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.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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 | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".