Efficacy and safety of iclepertin (BI 425809) with adjunctive computerized cognitive training in patients with schizophrenia
Bibliographic record
Abstract
Despite significant patient burden, there are no approved pharmacotherapies to treat symptoms of cognitive impairment associated with schizophrenia (CIAS). This double-blind, placebo-controlled, parallel-group Phase II trial assessed the efficacy and safety of pharmacological augmentation of at-home computerized cognitive training (CCT) with iclepertin (BI 425809, a glycine transporter-1 inhibitor). Participants with schizophrenia (aged 18-50 years) on stable antipsychotic therapy, who were compliant with CCT during the run-in period, were enrolled. Patients were randomized (1:1) to once daily iclepertin 10 mg or placebo for 12 weeks, and all patients completed adjunctive CCT. At Week 12, the change from baseline in neurocognitive composite T-score of the MATRICS Consensus Cognitive Battery (primary endpoint), Schizophrenia Cognition Rating Scale interviewer total score, and Positive and Negative Syndrome Scale total score (secondary endpoints) were assessed. Performance was also assessed using Virtual Reality Functional Capacity Assessment Tool adjusted total time T-score. Of 200 randomized patients, 154 (77.0 %) completed the trial. At efficacy endpoint assessment, no differences were observed between treatment groups. Adverse events (AEs) were reported by 39 patients in the iclepertin 10 mg + CCT group and 57 patients in the placebo + CCT group; most AEs were mild to moderate. To our knowledge, this trial is the largest of its kind combining daily pharmacotherapy for CIAS with at-home CCT. Although efficacy was not demonstrated, the safety profile of iclepertin 10 mg was consistent with previous studies and no new risks were identified. Clinical trial registration: ClinicalTrials.gov identifier: NCT03859973.
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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| 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".