Effects of Adjunctive Brexpiprazole in Major Depressive Disorder Analyzed by Baseline Anxiety Level
Bibliographic record
Abstract
PURPOSE/BACKGROUND: In patients with major depressive disorder (MDD), anxiety symptoms are common and associated with reduced treatment response. In an 8-week, phase 4, open-label study (ENGAGE), patients with MDD and inadequate antidepressant treatment response showed improvements in patient life engagement, depressive symptoms, and anxiety symptoms following treatment with adjunctive brexpiprazole 0.5 to 2 mg/d. This post hoc analysis of ENGAGE aimed to characterize the utility of adjunctive brexpiprazole in clinically relevant subgroups by baseline anxiety level. METHODS/PROCEDURES: Baseline anxiety subgroups were based on the 7-item Generalized Anxiety Disorder scale total score: no/mild (<10), moderate (10 to 14), and severe (>14). In each subgroup, changes in the 10-item Inventory of Symptomatology Self-Report (IDS-SR 10 ) Life Engagement subscale score, IDS-SR total score, and other efficacy outcomes were determined. Safety was also analyzed. FINDINGS/RESULTS: One hundred twenty patients received adjunctive brexpiprazole, of whom 30 (25.0%) had no/mild anxiety, 43 (35.8%) had moderate anxiety, and 47 (39.2%) had severe anxiety at baseline. On IDS-SR 10 Life Engagement subscale score and IDS-SR total score, improvements (nominal P <0.001) from baseline to week 8 were observed across all subgroups. Improvements were also observed on all other efficacy endpoints (nominal P <0.05 in all subgroups). Incidence of treatment-emergent adverse events was 76.7% (no/mild baseline anxiety), 72.1% (moderate baseline anxiety), and 57.4% (severe baseline anxiety). No new safety signals were observed. IMPLICATIONS/CONCLUSIONS: Over 8 weeks, adjunctive brexpiprazole was associated with improvements in patient life engagement and depressive symptoms, regardless of baseline anxiety level. This observation may assist clinical decision-making when treating patients with MDD with/without anxiety symptoms.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 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 | 0.000 | 0.000 |
| 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".