Barbara Sebe - Academia.edu (original) (raw)
Papers by Barbara Sebe
Frontiers in Psychiatry
IntroductionMinimum clinically important difference (MCID) is a measure that defines the minimum ... more IntroductionMinimum clinically important difference (MCID) is a measure that defines the minimum amount of change in an objective score of a clinical test that must be reached for that change to be clinically noticeable. We aimed to find the MCID for patients with predominantly negative symptoms of schizophrenia at its earliest occurrence.MethodsData of a 26-week long, double-blind study with 454 patients [Positive and Negative Symptom Scale Negative Factor Score (PANSS-FSNS) ≥24, Positive and Negative Symptom Scale Positive Factor Score (PANSS-FSPS) ≤ 19] treated with cariprazine 4.5 mg/d or risperidone 4 mg/d were analyzed. The Clinical Global Impression—Improvement scale was used to quantify minimum improvement (CGI-I = 3) and no clinical change (CGI-I = 4) on the PANSS-FSNS, and the MCID was estimated with the following methods: as the mean PANSS-FSNS changes corresponding to the first instance of minimal improvement across all visits (MCID1); as the difference between the PANSS...
Frontiers in Psychiatry
BackgroundThe hierarchy of evidence coming from evidence-based medicine favors meta-analyses and ... more BackgroundThe hierarchy of evidence coming from evidence-based medicine favors meta-analyses and randomized controlled trials over observational studies and clinical cases. Nonetheless, in the field of psychiatry, where conditions are much more complex, additional evidence coming from real-world clinical practice is necessary to complement data from these gold standards. Thus, in this systematic review, the aim is to summarize the evidence coming from clinical case reports regarding cariprazine, a third-generation antipsychotic drug that has been approved for the treatment of schizophrenia and bipolar I disorder with manic, depressive or mixed features in adults.MethodsA systematic review was performed using Embase and Pubmed databases searching for English-language cases published in peer-reviewed journals between 2000 January and 2021 September with the following search terms: (cariprazin* OR “rgh-188” OR rgh188 OR vraylar OR reagila) AND (“case report*” OR “case report”/de OR “ca...
![Research paper thumbnail of Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies [Corrigendum]](https://attachments.academia-assets.com/82873703/thumbnails/1.jpg)
](Neuropsychiatric Disease and Treatment
The authors have advised that there are errors in the first row of Table 5 on page 963. Cariprazi... more The authors have advised that there are errors in the first row of Table 5 on page 963. Cariprazine 4.5 mg column, the value "1 (0.0)" should read "1 (0.2)". Cariprazine 6 mg column, "2 (0.0)" should read "2 (0.3)". Total 1.5-6 mg/d column, "0" should read "3 (0.1)".
Frontiers in Psychiatry
Schizophrenia is a lifelong mental disorder, affecting young adolescents to elderly patients. Ant... more Schizophrenia is a lifelong mental disorder, affecting young adolescents to elderly patients. Antipsychotic treatment is indicated for all patients with schizophrenia, including the very young and old as well. Developmental issues in the young and decline in organ functioning in the elderly could influence reactions to the drug, and require different dosing regimens. The aim of the present article was to examine the safety profile and dosing requirements in adolescent (13 to less than 18) and elderly (65 and above) patients treated with cariprazine. Data from two clinical studies (one pharmacokinetic pediatric study and one phase III clinical trial) on 49 adolescent patients and 17 elderly patients (65 years of age or above) treated with cariprazine was examined. Safety measures included assessment of adverse events (AEs), clinical laboratory values, physical examinations, extrapyramidal symptom (EPS)-, depression-, and suicidality rating scales. Safety parameters were summarized using descriptive statistics. Results indicate that cariprazine was generally safe and well tolerated. Adverse events in the marginal age populations were comparable to the adult population, except for less insomnia in the young and no reports of akathisia in the elderly. Laboratory parameters, vital sign values and EEG parameters were comparable to previously published data in the adult population. In conclusion, cariprazine in the approved adult dose-range of 1.5-6 mg might be a safe treatment option also in adolescent and elderly patients with schizophrenia. Further studies are need to verify these preliminary findings.
Therapeutic Advances in Neurological Disorders
Introduction: Wernicke encephalopathy (WE) and Wernicke–Korsakoff syndrome (WKS) are well-known d... more Introduction: Wernicke encephalopathy (WE) and Wernicke–Korsakoff syndrome (WKS) are well-known disorders caused by thiamine deficiency. In addition to the classical concept of these diseases, some literature data suggest a connection between mitochondrial dysfunction and WE/WKS. Psychotic disorders and WKS seem to run in families, as the deficiency of the oxidative phosphorylation can be a trigger factor in psychotic events and WE/WKS as well. We present a patient harbouring the m.A3243G mtDNA mutation with the clinical and magnetic resonance imaging (MRI) findings of WKS who developed schizophrenia with predominantly negative symptoms some years later. Case presentation: A 27-year-old woman was referred to our clinic with severe weight loss after severe vomiting episodes, memory dysfunction and gait ataxia. Family history, as well as clinical, imaging and laboratory findings suggested a mitochondrial aetiology of her symptoms. Brain MRI detected bilateral mild thalamic lesions and...
Neuropsychiatric Disease and Treatment
Psychosis - Phenomenology, Psychopathology and Pathophysiology [Working Title], 2021
The aim of this chapter is to summarize the state-of-the-art knowledge of clinical staging in sch... more The aim of this chapter is to summarize the state-of-the-art knowledge of clinical staging in schizophrenia spectrum disorders. Clinical staging has been introduced to psychiatry in the past two decades. Its primary goal is to divide the course of the disorder into recognizable stages based on seriousness, development and symptom characteristics in order to better predict prognosis and to adopt the most appropriate treatment strategies. The first staging model was developed in 1982. Since then several distinct concepts of clinical staging in psychiatry have emerged. To date, there is no clinical consensus regarding which staging model is the gold standard, nonetheless when merging them together an integrated staging concept arises. The integrated staging model of schizophrenia spectrum disorders is composed of four stages. The chapter will introduce the different staging models in a historical order as well as present the integrated staging model detailing the characteristics, timel...
European Psychiatry
Introduction: The Positive and Negative Syndrome Scale (PANSS) is widely used in schizophrenia an... more Introduction: The Positive and Negative Syndrome Scale (PANSS) is widely used in schizophrenia and has been divided into distinct factors (5-factor models) and sub-factors. Network analyses are newer in psychiatry and can help to better understand the relationships and interactions between the symptoms of a psychiatric disorder. The aim of this study was threefold: 1, to evaluate connections between schizophrenia symptoms in 2 populations of patients (patients in the acutely exacerbated phase of schizophrenia and patients with predominant negative symptoms [PNS]), and 2, to test whether network analyses support the Mohr 5 factor model of the PANSS and the Kahn 2 factor model of negative symptoms, and finally 3, to identify the most central symptoms in the two populations. Methods: Using pooled baseline data from 4 cariprazine clinical trials in patients with acute exacerbation of schizophrenia (n=2193) and the cariprazine-risperidone study in patients with PNS (n=460), separate network analyses were performed. Network structures were estimated for all 30 items of the PANSS. Results: While negative symptoms in patients with an acute exacerbation of schizophrenia are correlated with other PANSS symptoms, these negative symptoms are not correlated with other PANSS symptoms in patients with PNS. The Mohr factors were partially reflected in the network analyses. The 2 most central symptoms (largest node strength) were delusions and uncooperativeness in acute-phase patients and hostility and delusions in patients with PNS. Conclusion: This network analysis suggests that symptoms of schizophrenia are differently structured in acute and PNS patients. While in the former, negative symptoms are mainly secondary, in patients with PNS, they are mainly primary. Further, primary negative symptoms are better conceptualized as distinct negative symptom dimensions of the PANSS.
International Clinical Psychopharmacology
Frontiers in Psychiatry
IntroductionMinimum clinically important difference (MCID) is a measure that defines the minimum ... more IntroductionMinimum clinically important difference (MCID) is a measure that defines the minimum amount of change in an objective score of a clinical test that must be reached for that change to be clinically noticeable. We aimed to find the MCID for patients with predominantly negative symptoms of schizophrenia at its earliest occurrence.MethodsData of a 26-week long, double-blind study with 454 patients [Positive and Negative Symptom Scale Negative Factor Score (PANSS-FSNS) ≥24, Positive and Negative Symptom Scale Positive Factor Score (PANSS-FSPS) ≤ 19] treated with cariprazine 4.5 mg/d or risperidone 4 mg/d were analyzed. The Clinical Global Impression—Improvement scale was used to quantify minimum improvement (CGI-I = 3) and no clinical change (CGI-I = 4) on the PANSS-FSNS, and the MCID was estimated with the following methods: as the mean PANSS-FSNS changes corresponding to the first instance of minimal improvement across all visits (MCID1); as the difference between the PANSS...
Frontiers in Psychiatry
BackgroundThe hierarchy of evidence coming from evidence-based medicine favors meta-analyses and ... more BackgroundThe hierarchy of evidence coming from evidence-based medicine favors meta-analyses and randomized controlled trials over observational studies and clinical cases. Nonetheless, in the field of psychiatry, where conditions are much more complex, additional evidence coming from real-world clinical practice is necessary to complement data from these gold standards. Thus, in this systematic review, the aim is to summarize the evidence coming from clinical case reports regarding cariprazine, a third-generation antipsychotic drug that has been approved for the treatment of schizophrenia and bipolar I disorder with manic, depressive or mixed features in adults.MethodsA systematic review was performed using Embase and Pubmed databases searching for English-language cases published in peer-reviewed journals between 2000 January and 2021 September with the following search terms: (cariprazin* OR “rgh-188” OR rgh188 OR vraylar OR reagila) AND (“case report*” OR “case report”/de OR “ca...
Neuropsychiatric Disease and Treatment
The authors have advised that there are errors in the first row of Table 5 on page 963. Cariprazi... more The authors have advised that there are errors in the first row of Table 5 on page 963. Cariprazine 4.5 mg column, the value "1 (0.0)" should read "1 (0.2)". Cariprazine 6 mg column, "2 (0.0)" should read "2 (0.3)". Total 1.5-6 mg/d column, "0" should read "3 (0.1)".
Frontiers in Psychiatry
Schizophrenia is a lifelong mental disorder, affecting young adolescents to elderly patients. Ant... more Schizophrenia is a lifelong mental disorder, affecting young adolescents to elderly patients. Antipsychotic treatment is indicated for all patients with schizophrenia, including the very young and old as well. Developmental issues in the young and decline in organ functioning in the elderly could influence reactions to the drug, and require different dosing regimens. The aim of the present article was to examine the safety profile and dosing requirements in adolescent (13 to less than 18) and elderly (65 and above) patients treated with cariprazine. Data from two clinical studies (one pharmacokinetic pediatric study and one phase III clinical trial) on 49 adolescent patients and 17 elderly patients (65 years of age or above) treated with cariprazine was examined. Safety measures included assessment of adverse events (AEs), clinical laboratory values, physical examinations, extrapyramidal symptom (EPS)-, depression-, and suicidality rating scales. Safety parameters were summarized using descriptive statistics. Results indicate that cariprazine was generally safe and well tolerated. Adverse events in the marginal age populations were comparable to the adult population, except for less insomnia in the young and no reports of akathisia in the elderly. Laboratory parameters, vital sign values and EEG parameters were comparable to previously published data in the adult population. In conclusion, cariprazine in the approved adult dose-range of 1.5-6 mg might be a safe treatment option also in adolescent and elderly patients with schizophrenia. Further studies are need to verify these preliminary findings.
Therapeutic Advances in Neurological Disorders
Introduction: Wernicke encephalopathy (WE) and Wernicke–Korsakoff syndrome (WKS) are well-known d... more Introduction: Wernicke encephalopathy (WE) and Wernicke–Korsakoff syndrome (WKS) are well-known disorders caused by thiamine deficiency. In addition to the classical concept of these diseases, some literature data suggest a connection between mitochondrial dysfunction and WE/WKS. Psychotic disorders and WKS seem to run in families, as the deficiency of the oxidative phosphorylation can be a trigger factor in psychotic events and WE/WKS as well. We present a patient harbouring the m.A3243G mtDNA mutation with the clinical and magnetic resonance imaging (MRI) findings of WKS who developed schizophrenia with predominantly negative symptoms some years later. Case presentation: A 27-year-old woman was referred to our clinic with severe weight loss after severe vomiting episodes, memory dysfunction and gait ataxia. Family history, as well as clinical, imaging and laboratory findings suggested a mitochondrial aetiology of her symptoms. Brain MRI detected bilateral mild thalamic lesions and...
Neuropsychiatric Disease and Treatment
Psychosis - Phenomenology, Psychopathology and Pathophysiology [Working Title], 2021
The aim of this chapter is to summarize the state-of-the-art knowledge of clinical staging in sch... more The aim of this chapter is to summarize the state-of-the-art knowledge of clinical staging in schizophrenia spectrum disorders. Clinical staging has been introduced to psychiatry in the past two decades. Its primary goal is to divide the course of the disorder into recognizable stages based on seriousness, development and symptom characteristics in order to better predict prognosis and to adopt the most appropriate treatment strategies. The first staging model was developed in 1982. Since then several distinct concepts of clinical staging in psychiatry have emerged. To date, there is no clinical consensus regarding which staging model is the gold standard, nonetheless when merging them together an integrated staging concept arises. The integrated staging model of schizophrenia spectrum disorders is composed of four stages. The chapter will introduce the different staging models in a historical order as well as present the integrated staging model detailing the characteristics, timel...
European Psychiatry
Introduction: The Positive and Negative Syndrome Scale (PANSS) is widely used in schizophrenia an... more Introduction: The Positive and Negative Syndrome Scale (PANSS) is widely used in schizophrenia and has been divided into distinct factors (5-factor models) and sub-factors. Network analyses are newer in psychiatry and can help to better understand the relationships and interactions between the symptoms of a psychiatric disorder. The aim of this study was threefold: 1, to evaluate connections between schizophrenia symptoms in 2 populations of patients (patients in the acutely exacerbated phase of schizophrenia and patients with predominant negative symptoms [PNS]), and 2, to test whether network analyses support the Mohr 5 factor model of the PANSS and the Kahn 2 factor model of negative symptoms, and finally 3, to identify the most central symptoms in the two populations. Methods: Using pooled baseline data from 4 cariprazine clinical trials in patients with acute exacerbation of schizophrenia (n=2193) and the cariprazine-risperidone study in patients with PNS (n=460), separate network analyses were performed. Network structures were estimated for all 30 items of the PANSS. Results: While negative symptoms in patients with an acute exacerbation of schizophrenia are correlated with other PANSS symptoms, these negative symptoms are not correlated with other PANSS symptoms in patients with PNS. The Mohr factors were partially reflected in the network analyses. The 2 most central symptoms (largest node strength) were delusions and uncooperativeness in acute-phase patients and hostility and delusions in patients with PNS. Conclusion: This network analysis suggests that symptoms of schizophrenia are differently structured in acute and PNS patients. While in the former, negative symptoms are mainly secondary, in patients with PNS, they are mainly primary. Further, primary negative symptoms are better conceptualized as distinct negative symptom dimensions of the PANSS.
International Clinical Psychopharmacology