Naturalistic studies – Researching the everyday clinical world

Malm, Ulf; Fedovskiy, Kaney; Eberhard, Jonas

doi:10.1080/08039480902786542

Cited by 2 publications

(2 citation statements)

References 10 publications

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“…While randomized controlled trials (RCTs) are considered to be the gold standard in clinical research by providing high-quality data on efficacy, there is a considerable need for conducting studies that measure the effectiveness and the performance of compounds in everyday practice (Malm et al ., 2009). Observational and naturalistic studies can provide important information regarding the safety, effectiveness and appropriate usage of drugs in the real world (Van Vollenhoven and Severens, 2011).…”

Section: Introductionmentioning

confidence: 99%

The effectiveness and safety of cariprazine in schizophrenia patients with negative symptoms and insufficient effectiveness of previous antipsychotic therapy: an observational study

Rancāns

Dombi

Mátrai

et al. 2021

International Clinical Psychopharmacology

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The aim of the study was to examine the effectiveness and safety of cariprazine in routine psychiatric settings on schizophrenia patients with negative symptoms who have been treated with antipsychotics previously but without sufficient success. This was an open-label, flexible-dose, 16-week, observational study in Latvia. The primary outcome measure was an array of anamnesisbased clinical questions on schizophrenia symptoms rated on a seven-point scale. Other outcome measurements were the clinical global impression improvement (CGI-I) and severity (CGI-S) scales. Safety parameters included spontaneous reports of adverse events and specific assessments of extrapyramidal side-effects. A mixed model for repeated measures was fit to the data to evaluate the mean change from baseline for all visits. A total of 116 patients enrolled in the study (completion: 83%). Change from baseline to termination in symptom control was statistically significant (−7.3; P < 0.001), with the most improvement in negative symptoms (−6.3; P < 0.001). Over 70% of patients improved minimally or much based on the CGI-I scores at the final visit, and the CGI-S scores indicated an overall improvement in severity from moderately to mildly ill. 40% of patients experienced treatment-emergent adverse events. Over 70% of doctors were satisfied with the effectiveness and tolerability of cariprazine. Cariprazine significantly improved negative symptoms in schizophrenia patients.

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Section: Introductionmentioning

confidence: 99%

The effectiveness and safety of cariprazine in schizophrenia patients with negative symptoms and insufficient effectiveness of previous antipsychotic therapy: an observational study

Rancāns

Dombi

Mátrai

et al. 2021

International Clinical Psychopharmacology

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“…It is a well-known fact that randomized controlled trials (RCTs) are the gold standard in psychiatric research as they provide the highest quality data regarding the efficacy of a treatment (13). Nonetheless, participants in such trials are highly selected and therefore the "real" patients are often underrepresented (14,15).…”

Section: Introductionmentioning

confidence: 99%

Successful high dose antipsychotic treatment with cariprazine in patients on the schizophrenia spectrum: Real-world evidence from a Spanish hospital setting

Galmes

Rancāns²

2023

Front. Psychiatry

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Real-world evidence fills in an important gap by providing data on the effectiveness and tolerability of new medications in everyday patients. In this data collection form a Spanish hospital, the effectiveness and tolerability of cariprazine were evaluated in 14 patients who were admitted to the hospital due to an acute episode of schizophrenia or schizoaffective disorder. The collected data included demographic characteristics, history of disorder and previous treatment, and details of cariprazine therapy such as dosing, side effects and measurements of effectiveness via scales. Difference between admission and discharge on the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression-Severity (CGI-S) scale scores were evaluated using the Wilcoxon Signed-Rank test. Significant improvement was detected in nearly all patients (one patient dropped out) as measured by the BPRS Total, Negative symptom, Positive symptom, and Hostility scores. At admission, patients were markedly-moderately ill and at discharge the severity was reduced to borderline ill and normal according to the CGI-S. The CGI-Improvement scale also indicated very much and much improvement at discharge. Importantly, patients left the hospital with high doses of cariprazine, i.e., 7.5 mg/day or even 9.0 mg/day, but this did not cause safety problems; cariprazine well-tolerated as only a few patients experienced side effects such as akathisia. The results provide novel evidence regarding the tolerability and effectiveness of cariprazine in high doses patients on the schizophrenia spectrum.

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Naturalistic studies – Researching the everyday clinical world

Cited by 2 publications

References 10 publications

The effectiveness and safety of cariprazine in schizophrenia patients with negative symptoms and insufficient effectiveness of previous antipsychotic therapy: an observational study

The effectiveness and safety of cariprazine in schizophrenia patients with negative symptoms and insufficient effectiveness of previous antipsychotic therapy: an observational study

Successful high dose antipsychotic treatment with cariprazine in patients on the schizophrenia spectrum: Real-world evidence from a Spanish hospital setting

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