P2–388: A transition from compressed risperidone tablets to orally disintegrating risperidone tablets, does symptom decompensation occur?
Bibliographic record
Abstract
Orally disintegrating risperidone tablets (Risperdal* M–TABs*) present an alternative method of drug delivery that may benefit patients/physicians struggling with compliance and swallowing issues. An orally disintegrating formulation may help improve compliance and medication intake since it dissolves within 5 seconds (Chue et al, 2004). To evaluate safety and maintenance of effect in subjects transitioned from compressed risperidone tablets to orally disintegrating risperidone tablets. Patients≥18 years with a DSM–IV diagnosis of Major Depressive Disorder (MDD) or Dementia (D) with baseline CGI–Severity≤3 (mildly ill) and minimum of 2 weeks prior oral risperidone therapy at a stable dose of 0.5, 1.0 or 2.0 mg/day were recruited, then switched to an equivalent dose of orally disintegrating risperidone tablets and assessed 4 weeks later. Other psychotropic meds were permitted providing the dose was stable for a minimum of 4 weeks pre–entry and were expected to remain stable. Maintenance of effect was measured using the CGI–Severity scale. Secondarily, a Likert scale was used to measure the severity of anxiety, depression or psychotic symptoms present, ranging from 1=“none”, 2=“mild”, 3=“moderate”, 4=“marked”, 5=“severe”. All MDD patients were on pre–existing anti–depressants pre–study entry and most Dementia patients (13/20) were on a pre–existing cholinesterase inhibitor. N=25 (MDD), N=20 (D). Mean age=49.2+/–13.8 years(MDD), 77.6+/–8.7 years(D). Mean baseline CGI–S score=2.5 +/– 0.7(MDD), 2.8 +/– 0.4(D), with a mean improvement observed at Week 4 of –0.1 +/– 0.4(MDD), –0.3 +/– 0.6(D). The mean change in Likert score for anxiety symptoms at Week 4=–0.1 +/– 0.3(MDD), –0.2 +/– 0.6(D). Mean change in Likert score for depressive symptoms at Week 4= –0.1 +/– 0.3(MDD), –0.1 +/– 0.5(D). No change in Likert score for psychotic symptoms in the MDD group was observed, however the mean change at Week 4= –0.2 +/– 0.5(D). On a Visual Analogue Scale for acceptability of treatment, both diagnostic groups favorably rated orally disintegrating risperidone tablets, with patients rating acceptability at 6.4/10(MDD) and 7/10(D) respectively. The most frequent AE reported was headache. Orally disintegrating risperidone tablets offer an alternative, well–tolerated method of drug delivery with no evidence of symptom decompensation when transitioned from the previous risperidone formulation.
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.009 | 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".