Safety and efficacy of different initial doses of lurasidone in the schizophrenia treatment: A multi-center, randomized, open-label study
Bibliographic record
Abstract
BACKGROUND Schizophrenia, a complex group of mental disorders, is primarily managed with antipsychotic medications. The safety and efficacy of different initial doses of lurasidone for acute schizophrenia remain uncertain, particularly concerning discontinuation rates due to adverse events (AEs). AIM To compare the safety of two initial doses of lurasidone for the treatment of acute schizophrenia in Chinese patients. METHODS This 6-week, randomized, open-label, multicenter trial allocated participants to receive either 40 mg/day or 80 mg/day lurasidone initially, with dose adjustment allowed after a one-week fixed-dose period. Safety assessments included the primary endpoint of discontinuation due to AEs, as well as evaluations of AEs, weight changes, and laboratory parameters. Efficacy assessments included responder rates and changes in scores on the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity scale, and Calgary Depression Scale for Schizophrenia. RESULTS Among 197 participants, no significant difference was found in discontinuation rate due to AEs between groups (3.03% vs 5.10%, P = 0.707). Treatment-emergent AEs were reported in 64.6% and 71.4% of participants in the 40 mg/day and 80 mg/day initiation groups, respectively. Response rates at weeks 1 and 2 showed no statistically significant differences. Both groups demonstrated significant improvements in PANSS total, Clinical Global Impression-Severity, and Calgary Depression Scale for Schizophrenia scores from baseline (all P < 0.01). Notably, the 80 mg/day initiation group showed greater improvement in the PANSS positive subscale score at visits 1 and 2 compared to the 40 mg/day initiation group (P < 0.05). CONCLUSION Initial doses of 40 mg/day and 80 mg/day lurasidone are safe and effective for acute schizophrenia, with no significant increase in AEs-related discontinuation rate at the higher dose.
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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 | 0.005 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| 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".