Risperidone Treatment of Outpatients with Schizophrenia: No Evidence of Sex Differences in Treatment Response
Bibliographic record
Abstract
OBJECTIVE: Given the renewed interest in the role of sex differences in schizophrenia, we undertook a post hoc analysis to determine whether sex differences in treatment response were present among outpatients with schizophrenia who received risperidone in an 8-week, open-label, Phase IV clinical study. METHOD: We evaluated 330 adult patients (232 men, 98 women) with a DSM-III-R diagnosis of schizophrenia for safety and 292 (206 men, 86 women) for efficacy. Antipsychotic and antiparkinsonian medications were discontinued at study entry. Treatment with risperidone was initiated at a dosage of 2 mg daily, increased to the target dosage of 6 mg daily by day 3, and maintained at 6 mg daily until day 14. The dosage was then maintained at 6 mg daily, increased or decreased by 2 mg daily each week, based on the patient's response. Risperidone treatment was given for 8 weeks; the permitted dosage range was 4 mg to 10 mg daily. RESULTS: Both male and female participants responded well to risperidone treatment; by the final assessment day, they had experienced decreases from baseline in their total Positive and Negative Syndrome Scale (PANSS) scores of 41.0% and 36.5%, respectively. Most male (77%) and female (78%) participants were considered to be PANSS responders: risperidone was effective against both the positive and negative symptoms of schizophrenia. Both sexes showed improvements over baseline in the incidence and severity of parkinsonism, dystonia, and dyskinesia. No significant (P > 0.05) sex differences in treatment response were observed for any of the efficacy outcomes or in the incidence and severity of extrapyramidal symptoms (EPS). CONCLUSIONS: In this population of outpatients with chronic schizophrenia, both men and women responded well to flexible doses of risperidone. No significant sex differences were evident either in treatment response or in neurological side effects. The absence of sex differences in response to risperidone treatment may obviate the need for a sex-based differential dosing in schizophrenia management.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 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 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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 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".