648. A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED TRIAL OF LURASIDONE IN IMPROVING COGNITIVE IMPAIRMENT IN EUTHYMIC PATIENTS WITH BIPOLAR DISORDER
Bibliographic record
Abstract
Abstract Background 5-HT7 receptor antagonists have been shown to modulate cognitive function in pre-clinical studies. In a pilot RCT, we have previously demonstrated that lurasidone add-on significantly improves cognitive function in patients with bipolar disorder (BD) compared with treatment as usual. Aims & Objectives in a large RCT, we assessed the efficacy of lurasidone vs placebo adjunctive therapy in improving cognitive function in euthymic patients with BD who had cognitive impairment at study entry. Method 100 patients with BD were recruited and randomized to lurasidone or placebo adjunctive therapy from Canada, Japan, the US and the UK. All patients were euthymic at study entry and had cognitive impairment at least 0.5 SD below the expected norm. Primary outcome was composite cognitive score change from baseline to end point using the ISBD-BANC. Results Of the 100 recruited, 2 dropped out without completing the post-baseline ISBD-BANC, leaving 98 eligible patients for analysis. Majority of patients were recruited from 5 sites in Japan, Vancouver and London. The results are being analyzed and will be presented at the conference. Discussion & Conclusions This will be the first large double blind RCT to assess the efficacy of Lurasidone in euthymic bipolar patients. The results will provide important insights into the role of 5-HT7 receptor antagonists in cognition.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.016 | 0.002 |
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".