Real-world effectiveness of cariprazine in major depressive disorder and bipolar I disorder in the United States
Bibliographic record
Abstract
Aims The efficacy of cariprazine for major depressive disorder (MDD) (adjunctive therapy) and bipolar I (BP-I) depression has been demonstrated in clinical trials. This study evaluated the real-world effectiveness of cariprazine in reducing depression severity among patients with moderate-to-severe MDD or BP-I depression.Methods Medical/pharmacy claims and electronic medical records (EMRs) from specialty providers in the OM1 Real-World Data Cloud were used to identify adults with MDD or BP-I who initiated cariprazine (adjunctively for MDD) (first dispensing = index) and had ≥1 EMR and ≥1 claim during 12-month baseline and ≤12-month follow-up periods. Included patients had a baseline Patient Health Questionnaire (PHQ)-9 total score ≥10, reflecting at least moderate depressive symptoms. Follow-up continued until cariprazine discontinuation, alternate diagnosis (e.g., BP-I [MDD cohort] or MDD [BP-I cohort]), or 12 months post-index. Depression severity was assessed using PHQ-9 total scores that were observed or estimated from clinical notes using a previously validated machine learning algorithm. Analyses included mean change in PHQ-9 score from baseline to 2, 6, and 12 months of follow-up. A sensitivity analysis using only observed PHQ-9 scores was conducted.Results Of 754 patients at baseline, 396 had MDD (mean PHQ-9 = 16.4) and 358 had BP-I (mean PHQ-9 = 16.9). For patients with MDD, mean reductions in PHQ-9 scores from baseline to 2, 6, and 12 months of adjunctive cariprazine treatment were 3.5 (95% CI: 2.7, 4.4; n = 127), 4.1 (2.9, 5.4; n = 87), and 3.7 (1.6, 5.8; n = 52), respectively. For patients with BP-I, mean reductions from baseline to 2, 6, and 12 months were 5.2 (95% CI: 4.2, 6.2; n = 121), 6.5 (5.2, 7.8; n = 90), and 6.9 (5.2, 8.5; n = 54), respectively. Greater improvements were observed in the sensitivity analysis.Conclusions This real-world effectiveness study of cariprazine treatment for MDD (adjunctive use) or BP-I demonstrated clinically meaningful and sustained improvement in depression symptoms during short- and long-term follow-up.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 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 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 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".