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1.
Eur Arch Psychiatry Clin Neurosci ; 270(6): 661-671, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-31463563

RESUMEN

Aim of the study was to examine the course of schizophrenia patients within 2 years after discharge. Within a multicenter study of the German Competence Network on Schizophrenia, patients suffering from a schizophrenia spectrum disorder were examined regarding their psychopathological improvement, tolerability, and the treatment regime applied during hospitalization and a 2-year follow-up period. Response, remission, the level of everyday functioning, and relapse were furthermore evaluated during the follow-up period using established definitions for these outcome domains. The psychopharmacological treatment was specifically evaluated in terms of a potential association with relapse. 149 patients were available for analysis, with 65% of the patients being in response, 52% in symptomatic remission, and 64% having a satisfiable everyday functioning 2 years after their discharge from hospital. Despite these favorable outcome rates, 63% of the patients suffered from a relapse within the 2-year follow-up period with 86% of these patients being rehospitalized. Discharge non-responder and non-remitter were twice as likely to relapse during follow-up. A significant decrease of side-effects was observed with negligible rates of extrapyramidal side-effects, sedation, and weight gain during follow-up. Patients receiving treatment with atypical antipsychotics were found to have the lowest risk to relapse (p < 0.0001). The results highlight the natural and unsteady course of schizophrenia in most patients underlining the need to develop more specific treatment strategies ensuring ongoing stability and preventing relapse.


Asunto(s)
Antipsicóticos/administración & dosificación , Cumplimiento de la Medicación/estadística & datos numéricos , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Alta del Paciente/estadística & datos numéricos , Readmisión del Paciente/estadística & datos numéricos , Trastornos Psicóticos/terapia , Esquizofrenia/terapia , Actividades Cotidianas , Adulto , Antipsicóticos/efectos adversos , Progresión de la Enfermedad , Femenino , Estudios de Seguimiento , Alemania , Humanos , Masculino , Persona de Mediana Edad , Trastornos Psicóticos/tratamiento farmacológico , Recurrencia , Inducción de Remisión , Esquizofrenia/tratamiento farmacológico , Adulto Joven
2.
Int J Neuropsychopharmacol ; 20(1): 40-49, 2017 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-27927736

RESUMEN

Background: QUALIFY was a 28-week, randomized, open-label, head-to-head trial that assessed improvements across multiple measures in stable patients with schizophrenia with aripiprazole once-monthly 400 mg vs paliperidone palmitate. Methods: Secondary effectiveness assessments included physician-rated readiness for work using the Work Readiness Questionnaire, the Clinical Global Impression-Severity and Clinical Global Impression-Improvement scales, and quality of life with the rater-blinded Heinrichs-Carpenter Quality of Life Scale. Patients assessed their treatment satisfaction and quality of life with Subjective Well-Being under Neuroleptic Treatment-short version and Tolerability and Quality of Life questionnaires. Results: Odds of being ready for work at week 28 were significantly higher with aripiprazole once-monthly 400 mg vs paliperidone palmitate (adjusted odds ratio, 2.67; 95% CI, 1.39-5.14; P=.003). Aripiprazole once-monthly 400 mg produced numerically or significantly greater improvements from baseline vs paliperidone palmitate in all Quality of Life Scale items. With aripiprazole once-monthly 400 mg vs paliperidone palmitate at week 28, there were significantly more Clinical Global Impression-Severity and Clinical Global Impression-Improvement responders (adjusted odds ratio, 2.26; P=.010, and 2.51; P=.0032) and significantly better Clinical Global Impression-Improvement scores (least squares mean treatment difference, -0.326; 95% CI, -0.60 to -0.05; P=.020). Numerically larger improvements with aripiprazole once-monthly 400 mg vs paliperidone palmitate were observed for patient-rated scales Subjective Well-Being under Neuroleptic Treatment-short version and Tolerability and Quality of Life. Partial correlations were strongest among clinician-rated and among patient-rated scales but poorest between clinician and patient-rated scales. Conclusions: Consistently greater improvements were observed with aripiprazole once-monthly 400 mg vs paliperidone palmitate across all measures. Partial correlations between scales demonstrate the multidimensionality of various measures of improvement. More patients on aripiprazole once-monthly 400 mg were deemed ready to work by the study end. Trial registry: National Institutes of Health registry, NCT01795547, https://clinicaltrials.gov/ct2/results?id=NCT01795547).


Asunto(s)
Antipsicóticos/uso terapéutico , Aripiprazol/uso terapéutico , Palmitato de Paliperidona/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Adulto , Antipsicóticos/efectos adversos , Aripiprazol/efectos adversos , Empleo , Femenino , Humanos , Masculino , Palmitato de Paliperidona/efectos adversos , Satisfacción del Paciente , Escalas de Valoración Psiquiátrica , Calidad de Vida , Índice de Severidad de la Enfermedad , Método Simple Ciego , Encuestas y Cuestionarios , Resultado del Tratamiento
3.
Eur Arch Psychiatry Clin Neurosci ; 267(4): 303-313, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-27785605

RESUMEN

The objective of the present study was the application and comparison of common remission and recovery criteria between patients with the diagnosis of schizophrenia and major depressive disorder (MDD) under inclusion of other outcome parameters. Patients with schizophrenia and MDD who were treated as inpatients at the beginning of the study were examined within two naturalistic follow-up trials from admission to discharge of an inpatient treatment period and the one-year follow-up assessment. PANSS criteria of the Remission in Schizophrenia Working Group (RSWG) for schizophrenia and HAMD criteria of the ACNP Task Force in MDD for depressive patients as well as the Clinical Global Impression-Severity Scale (CGI-S) were applied as symptomatic outcome measures additionally to functional outcome parameters. Data of 153 schizophrenia patients and 231 patients with a MDD episode have been included in the analysis. More depressive than schizophrenia patients reached a threshold score of ≤3 on the CGI-S, indicating symptomatic remission at discharge and at the one-year follow-up. In contrast similar proportions of patients reaching symptomatic remission at discharge from inpatient treatment and at the one-year follow-up in the schizophrenia and in the MDD group were found when disease-related consensus criteria (RSWG vs. ACNP Task Force) were used. Functional remission and recovery rates were significantly lower in schizophrenia than in depressive patients at the one-year follow-up visit. Common outcome criteria for remission and recovery in schizophrenia and major depression were not directly comparable. However, our results indicated a significantly poorer outcome in schizophrenia than in depressive patients according to terms of remission and recovery.


Asunto(s)
Trastorno Depresivo Mayor , Evaluación de Resultado en la Atención de Salud , Recuperación de la Función/fisiología , Esquizofrenia/diagnóstico , Esquizofrenia/fisiopatología , Adulto , Trastorno Depresivo Mayor/diagnóstico , Trastorno Depresivo Mayor/fisiopatología , Trastorno Depresivo Mayor/psicología , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Femenino , Estudios de Seguimiento , Humanos , Pacientes Internos , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad
4.
Pharmacopsychiatry ; 50(4): 136-144, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28505669

RESUMEN

The aim of this study was to evaluate antidepressant add-on treatment within the acute treatment of schizophrenia spectrum disorder patients. Antidepressant add-on was evaluated in 365 patients within a naturalistic multicenter study. Patients with/without antidepressant add-on were compared regarding clinical and treatment-related variables, response and remission, and remission of depressive and negative symptoms. The efficacy of antidepressant add-on treatment was furthermore analyzed applying marginal structure models. Twenty-three percent of the patients received antidepressant add-on for a mean duration of 50.28 (33.42) days. Patients with the diagnosis of a schizoaffective disorder, multiple illness episodes, and a longer duration of their illness as well as those with significantly fewer baseline positive symptoms, more negative and depressive symptoms, more side effects, and less subjective well-being were augmented with antidepressants. At discharge no significant effect of antidepressant add-on treatment was observed in terms of a 25% improvement (p=0.2623), a 50% improvement (p=0.3946), remission (p=0.0552), or remission of depressive (p=0.6336) and negative symptoms (p=0.8756). Also, when analyzing marginal structure models considering the diagnostic subgroups, no significant effect was found. Add-on with antidepressants is common. A final recommendation in terms of this strategy's efficacy cannot be given.


Asunto(s)
Antidepresivos/uso terapéutico , Sinergismo Farmacológico , Esquizofrenia/tratamiento farmacológico , Adolescente , Adulto , Anciano , Antipsicóticos/uso terapéutico , Depresión/complicaciones , Depresión/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Esquizofrenia/complicaciones , Resultado del Tratamiento , Adulto Joven
5.
Eur Arch Psychiatry Clin Neurosci ; 265(2): 107-16, 2015 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25261210

RESUMEN

The aim of this study was to evaluate residual symptoms in patients achieving remission according to the consensus criteria and to analyze their potential influence on the patient's outcome one year after discharge. In total, 399 patients suffering from a schizophrenia spectrum disorder were evaluated within a naturalistic study. Remission status was examined using the consensus criteria. Residual symptoms were defined as any symptom present at the time-point of remission following analogous analyses performed in depressed patients. Therefore, a PANSS item with a symptom severity of >1 (= at least borderline mentally ill) was defined to be a residual symptom. Remitters with and without residual symptoms were compared regarding psychopathology, functioning and side effects. In total, 236 patients (59%) were remitters at discharge with 94% of them suffering from at least one residual symptom. The most common residual symptoms were blunted affect (49%), conceptual disorganization (42%) and social withdrawal (40%). A significant association was found between the presence of residual symptoms and the severity of side effects (p < 0.0001) and functioning (p = 0.0003) at discharge as well as between residual symptoms and the risk of relapse and chance of remission one year after discharge. Residual symptoms were highly prevalent in remitted schizophrenia inpatients following the suggested definition. Most residual symptoms were persistent baseline symptoms suggesting an ongoing illness severity. Also, the necessity to re-evaluate the consensus criteria questioning the status of remission in these patients is also pointed out.


Asunto(s)
Trastornos Psicóticos/diagnóstico , Esquizofrenia/complicaciones , Esquizofrenia/diagnóstico , Psicología del Esquizofrénico , Adulto , Análisis de Varianza , Antipsicóticos/uso terapéutico , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica , Psicopatología , Trastornos Psicóticos/complicaciones , Trastornos Psicóticos/tratamiento farmacológico , Recurrencia , Estudios Retrospectivos , Esquizofrenia/tratamiento farmacológico
6.
J Nerv Ment Dis ; 202(4): 319-23, 2014 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-24647216

RESUMEN

We assessed both current maladaptive personality traits (MPTs) and, retrospectively, premorbid MPTs in patients with schizophrenia spectrum disorders (SSDs). This was to examine whether the patients had the impression that their personality had changed and which traits were affected. We also wanted to determine whether the perceived changes could be explained by SSD psychopathology. MPTs were assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnoses, axis II disorders, screening questionnaire and interview, integrating questions on subjective estimation of premorbid MPTs in moderately ill SSD patients. Forty-five patients were included. Premorbid MPTs were remembered as significantly less pronounced than current MPTs for the whole spectrum of personality traits (p < 0.001). Antisocial traits had worsened significantly less (p < 0.001), and borderline and obsessive-compulsive traits had worsened significantly more (both p < 0.01) than the mean increase. Associations between MPT increase and SSD psychopathology were significant for schizotypal, avoidant, and depressive traits. According to the patients' retrospective assessment, MPTs increased through onset and course of SSDs. Memory bias, depressed mood, and SSD symptoms alone could not sufficiently explain these differences. Subjective MPT increase may play a role for the patients' concept of illness, quality of life, and adherence to therapeutic interventions. It should be addressed in SSD treatment.


Asunto(s)
Adaptación Psicológica/fisiología , Trastornos de la Personalidad/fisiopatología , Esquizofrenia/fisiopatología , Psicología del Esquizofrénico , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Trastornos de la Personalidad/etiología , Escalas de Valoración Psiquiátrica , Estudios Retrospectivos , Esquizofrenia/complicaciones
7.
Health Expect ; 16(2): 164-76, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-21668795

RESUMEN

BACKGROUND: While much discussion has been placed on the problem of poor compliance in the treatment of schizophrenia, there has been little discussion on the concordance between patients and psychiatrists, an important contributing factor to patient-centred care. OBJECTIVE: To estimate the concordance between patients' and psychiatrists' (ordinal and cardinal) valuations of multiple goals for schizophrenia treatment and to illustrate the utility of the self-explicated method in valuing a large number of treatment goals. DESIGN: Twenty treatment goals were identified during focus groups and literature review and were presented to patients and psychiatrists during structured interviews. Respondents were asked to rank the multiple treatment goals and rate them on a 5-point Likert scale. Three scores were calculated based on the ranking (1-20), rating (Likert scale) (1-5) and a self-explicated method estimated as the product of rating and ranking score (1-100). Concordance was tested using Spearman's rho for overall ordinal rankings and via anova and F-test for the cardinal values assigned to a specific treatment goal. PARTICIPANTS: A total of 105 outpatients diagnosed with schizophrenia and 160 psychiatrists in Germany. RESULTS: Patient and psychiatrist values were concordant when the ordinal properties of their valuations were assessed by rating (ρ = 0.63; P = 0.002), ranking (ρ = 0.51; P = 0.02) and self-explicated methods (ρ = 0.54; P = 0.01). Significant discordances were found when comparing the cardinal value placed on any given treatment goal using all three approaches, but the self-explicated method produced a more discerning statistic. Relative to patients, psychiatrists significantly (P < 0.05) overvalued reduced lack of emotion, improved sexual pleasure and improved communication while undervaluing reuptake of activities of daily living, improved satisfaction and recovered capacity for work. CONCLUSIONS: While there is an overall concordance between patients' and psychiatrists' valuation, significantly different valuations on specific goals can be identified. Here, psychiatrists tend to focus on 'textbook' outcomes, while patients are more concerned with functioning and living a normal life. This study also demonstrates the importance of comparing the concordance in treatment goals and the importance of preference-based methods, such as the self-explicated method, in the study of concordance.


Asunto(s)
Objetivos , Esquizofrenia/terapia , Adolescente , Adulto , Femenino , Grupos Focales , Humanos , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Psiquiatría/estadística & datos numéricos , Psicología del Esquizofrénico , Resultado del Tratamiento , Adulto Joven
8.
Neuropsychiatr Dis Treat ; 19: 219-232, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36721796

RESUMEN

Objective: To analyze the effect of Risperidone ISM on social functioning and health-related quality of life (HR-QoL) in both short- and long-term treatment of patients with schizophrenia. Patients and Methods: This analysis was based on data from both phases of the PRISMA-3 study, including 433 relapsed patients from the double-blind (DB) phase of the PRISMA-3 trial who were treated for 12-weeks with once-monthly (every 28 days) intramuscular Risperidone ISM 75 mg or 100 mg (n = 288), or placebo (n = 145), as well as 174 patients transitioning from the DB to an open-label 52-week extension (OLE) phase, plus 41 de novo patients treated on a stable maintenance dose of oral risperidone. The clinician-administered Personal and Social Performance (PSP) scale and the patient-reported 20-item Subjective Well-being under Neuroleptics scale (SWN-20) were used to measure social functioning and HR-QoL outcomes, respectively. Results: Risperidone ISM significantly improved PSP total score from baseline to endpoint (Day 85) versus placebo in the DB phase with mean change total score (95% CI) of 10.7 (9; 12) compared to 4.8 (3; 7) for placebo (p < 0.0001). The statistically significant improvement was present from the first measurement time point (Day 29). SWN-20-measured HR-QoL increased on average in patients treated with Risperidone ISM in the DB phase. A significant improvement was also observed for PSP and SWN-20 scores from the OLE baseline to week 52 for patients transitioning from the DB phase. Stable de novo patients maintained similar PSP and SWN-20 scores during the whole OLE phase. Conclusion: Risperidone ISM provided a rapid and sustained improvement in personal and social functioning, and HR-QOL without need of oral risperidone supplementation or loading doses. These findings, along with a fast onset of efficacy, could contribute to reinforcing the therapeutic alliance and possibly an earlier discharge. Moreover, patient functioning continued improving or was maintained with long-term treatment.

9.
Eur Arch Psychiatry Clin Neurosci ; 262(3): 207-16, 2012 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-22113521

RESUMEN

The interrelation between needs for care and quality of life has been described and replicated by several studies. The present work aims to add to the understanding of longitudinal interrelations between needs for care, quality of life, and other outcome measures by analyzing a sample of patients at the onset of schizophrenia. This study relied on data from the EUFEST trial, designed to compare first- and second-generation antipsychotics during 1 year. At baseline, 498 patients have been included. The first (baseline) and the last assessment (12 months after baseline) were used for the analyses. Predictors of quality of life were determined using regression analyses. We tested the complex longitudinal interrelations between baseline and outcome measures with structural equation models. Unmet needs were not definitively confirmed as a predictor of subsequent quality of life, unless unmet needs changing to no needs were separated from unmet needs changing to met needs. Each unmet need that changed to no need enhanced the quality of life (mean score 1-7) by 0.136 scale points. This study suggests that when studying quality of life and needs for treatment, it is crucial to differentiate whether unmet needs disappeared or whether they were met, as the former has a stronger impact on quality of life.


Asunto(s)
Necesidades y Demandas de Servicios de Salud , Calidad de Vida/psicología , Esquizofrenia/terapia , Psicología del Esquizofrénico , Adolescente , Adulto , Europa (Continente) , Femenino , Humanos , Estudios Longitudinales , Masculino , Escalas de Valoración Psiquiátrica , Análisis de Regresión , Estudios Retrospectivos , Esquizofrenia/diagnóstico , Esquizofrenia/fisiopatología , Adulto Joven
10.
Psychopathology ; 45(5): 276-85, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-22796716

RESUMEN

BACKGROUND: The aim of this study was to compare two measures of depression in patients with schizophrenia and schizophrenia spectrum disorder, including patients with delusional and schizoaffective disorder, to conclude implications for their application. SAMPLING AND METHODS: A total of 278 patients were assessed using the Calgary Depression Scale for Schizophrenia (CDSS) and the Hamilton Depression Rating Scale (HAMD-17). The Positive and Negative Syndrome Scale (PANSS) was also applied. At admission and discharge, a principal component analysis was performed with each depression scale. The two depression rating scales were furthermore compared using correlation and regression analyses. RESULTS: Three factors were revealed for the CDSS and HAMD-17 factor component analysis. A very similar item loading was found for the CDSS at admission and discharge, whereas results of the loadings of the HAMD-17 items were less stable. The first two factors of the CDSS revealed correlations with positive, negative and general psychopathology. In contrast, multiple significant correlations were found for the HAMD-17 factors and the PANSS subscores. Multiple regression analyses demonstrated that the HAMD-17 accounted more for the positive and negative symptom domains than the CDSS. CONCLUSIONS: The present results suggest that compared to the HAMD-17, the CDSS is a more specific instrument to measure depressive symptoms in schizophrenia and schizophrenia spectrum disorder, especially in acutely ill patients.


Asunto(s)
Depresión/diagnóstico , Trastorno Depresivo/diagnóstico , Escalas de Valoración Psiquiátrica , Esquizofrenia/complicaciones , Adolescente , Adulto , Anciano , Depresión/complicaciones , Depresión/psicología , Trastorno Depresivo/complicaciones , Trastorno Depresivo/psicología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Psicometría , Psicología del Esquizofrénico
11.
Psychiatr Q ; 83(2): 187-207, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22038270

RESUMEN

Remission and recovery are major outcome goals in schizophrenia yet their predictors have not been studied in detail. Therefore, 186 patients were examined regarding remission and recovery including their potential sociodemographic and clinical predictors 1 year after discharge. Remission was defined according to the consensus remission criteria and recovery following the definition by Liberman et al. (2002). Of the 186 patients 54% achieved remission and 26% recovery at the 1-year follow-up. The remission status at discharge was found to significantly influence remission and recovery at follow-up. A higher SOFAS score (P = 0.0002) as well as a positive attitude towards treatment at discharge (P = 0.0038) were identified to be significant predictors of remission at 1-year follow-up. Having a job (P = <0.0001) and being without pharmacological treatment at follow-up (P = 0.0113) were found to be significantly predictive of recovery. Our results underline the need to implement more specific treatment strategies to improve long-term outcome.


Asunto(s)
Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Alta del Paciente/estadística & datos numéricos , Esquizofrenia/rehabilitación , Psicología del Esquizofrénico , Adolescente , Adulto , Cuidados Posteriores/estadística & datos numéricos , Anciano , Empleo/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Amigos , Alemania , Humanos , Vida Independiente/estadística & datos numéricos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Cooperación del Paciente/estadística & datos numéricos , Escalas de Valoración Psiquiátrica/estadística & datos numéricos , Inducción de Remisión , Índice de Severidad de la Enfermedad , Participación Social , Apoyo Social , Factores Socioeconómicos , Adulto Joven
12.
Acad Psychiatry ; 36(3): 205-10, 2012 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-22751822

RESUMEN

OBJECTIVE: Psychiatric educators are often faced with students' negative attitudes toward psychiatry. A new type of seminar has been established in order to enable students to gain a deeper understanding of psychiatric illness. METHOD: A "cinemeducation seminar," combining a movie, a lecture, and a patient interview, has been established as part of the undergraduate curriculum at Hamburg Medical School, where 1,032 students attended 39 cinemeducation seminars between 2005 and 2008. A student evaluation covering different aspects of education took place after each seminar. RESULTS: The students valued the combination of a movie and a seminar and found the movie and the additional patient interview useful for accessing the subject of Psychiatry and understanding the underlying psychiatric illnesses shown in the movies. CONCLUSION: From the students' perspective, this type of seminar seems to be helpful for providing an impression of psychiatric illnesses and enabling students to put themselves in the position of a person suffering from these illnesses. Therefore, we judged the cinemeducation seminar to be an appropriate teaching format in undergraduate medical education.


Asunto(s)
Actitud del Personal de Salud , Educación de Pregrado en Medicina/métodos , Películas Cinematográficas , Psiquiatría/educación , Estudiantes de Medicina/psicología , Adulto , Curriculum , Femenino , Humanos , Masculino , Encuestas y Cuestionarios
13.
Schizophr Res ; 239: 83-91, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34847501

RESUMEN

OBJECTIVE: To evaluate long-term efficacy, safety and tolerability of Risperidone ISM® in patients with schizophrenia, a multicenter, open-label extension of the PRISMA-3 study was conducted. METHODS: Eligible placebo (unstable) and Risperidone ISM® (stabilized) rollover patients from a previous 12-week double-blind phase and de novo stable patients received once-monthly intramuscular injections of Risperidone ISM® 75 or 100 mg for 12 months. The long term-efficacy assessment included the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales. Safety evaluation included treatment-emergent adverse events (TEAEs), injection site reactions (ISR), laboratory tests and several safety scales. RESULTS: Altogether, 215 patients entered the study (55 unstable, 119 stabilized and 41 stable patients). Most patients (74.9%) completed, and discontinuation rates were broadly similar across the study subgroups, mainly due to withdrawal of consent (12.1%). PANSS total and subscales scores decreased from baseline to endpoint in all groups, with the largest decrease for unstable patients. Improvement from baseline to 12 months was also shown for CGI-S and CGI-I scores for both unstable and stabilized patients; the CGI-S and CGI-I scores remained almost unchanged for the stable group. At least one treatment-related TEAE was reported in 39.1% of patients; the most common were headache (12.1%), hyperprolactinemia (9.8%) and asthenia (5.1%). ISR were reported in 8 (0.3%) patients; injection site pain score was low across the 2355 doses assessed. CONCLUSION: Risperidone ISM® is an effective, safe, and well-tolerated long-term treatment of schizophrenia in adults, regardless of the initial disease severity or whether patients were previously treated with Risperidone ISM® during an acute exacerbation or switched from stable doses of oral risperidone.


Asunto(s)
Antipsicóticos , Risperidona , Esquizofrenia , Adulto , Antipsicóticos/administración & dosificación , Antipsicóticos/uso terapéutico , Preparaciones de Acción Retardada/uso terapéutico , Humanos , Escalas de Valoración Psiquiátrica , Risperidona/administración & dosificación , Risperidona/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Resultado del Tratamiento
14.
Schizophr Bull ; 48(6): 1273-1283, 2022 11 18.
Artículo en Inglés | MEDLINE | ID: mdl-35857811

RESUMEN

BACKGROUND AND HYPOTHESIS: Meta-analyses have shown that the majority of patients with schizophrenia who have not improved after 2 weeks of treatment with an antipsychotic drug are unlikely to fully respond later. We hypothesized that switching to another antipsychotic with a different receptor binding profile is an effective strategy in such a situation. STUDY DESIGN: In total, 327 inpatients with an acute exacerbation of schizophrenia were randomized to double-blind treatment with either olanzapine (5-20 mg/day) or amisulpride (200-800 mg/day). Those patients who had not reached at least 25% Positive-and-Negative-Syndrome-Scale (PANSS) total score reduction from baseline after 2 weeks (the "non-improvers") were rerandomized double-blind to either staying on the same compound ("stayers") or to switching to the other antipsychotic ("switchers") for another 6 weeks. The primary outcome was the difference in the number of patients in symptomatic remission between the combined "switchers" and the "stayers" after 8 weeks of treatment, analyzed by logistic regression. STUDY RESULTS: A total of 142 nonimprovers were rerandomized at week two. 25 (45.5 %) of the 'stayers' compared to 41 (68.3 %) of the "switchers" reached remission at endpoint (p = .006). Differences in secondary efficacy outcomes were not significant, except for the PANSS negative subscore and the Clinical-Global-Impression-Scale. "Switchers" and "stayers" did not differ in safety outcomes. CONCLUSIONS: Switching "non-improvers" from amisulpride to olanzapine or vice-versa increased remission rates and was safe. The superiority in the primary outcome was, however, not paralleled by significant differences in most secondary efficacy outcomes and the effect was only apparent at the last visit making replications of longer duration necessary.


Asunto(s)
Antipsicóticos , Esquizofrenia , Humanos , Antipsicóticos/efectos adversos , Olanzapina/farmacología , Olanzapina/uso terapéutico , Amisulprida/farmacología , Amisulprida/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Benzodiazepinas/efectos adversos , Resultado del Tratamiento , Método Doble Ciego
15.
J Clin Psychopharmacol ; 31(2): 226-30, 2011 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-21346606

RESUMEN

OBJECTIVE: This study examined the differential effects of first- (FGAs) versus second-generation antipsychotics (SGAs) on subjective well-being in patients with schizophrenia. METHOD: Data were collected in an observational 3-year follow-up study of 2224 patients with schizophrenia. Subjective well-being was assessed with the Subjective Well-being under Neuroleptic Treatment Scale (SWN-K). Differential effects of FGAs versus SGAs were analyzed using marginal structural models in those patients taking antipsychotic monotherapy. RESULTS: The marginal structural model, which analyzed the differential effect on the SWN-K total score, revealed that patients on SGAs had significantly higher SWN-K total scores, starting at 6 months (3.02 points; P = 0.0061, d = 0.20) and remaining significant thereafter (end point: 5.35 points; P = 0.0074, d = 0.36). CONCLUSIONS: Results of this large observational study are consistent with a small but clinically relevant superiority of SGAs over FGAs in subjective well-being extending previous positive findings of differential effects on quality of life.


Asunto(s)
Antipsicóticos/uso terapéutico , Modelos Biológicos , Satisfacción del Paciente , Esquizofrenia/tratamiento farmacológico , Psicología del Esquizofrénico , Adulto , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos
16.
BMC Psychiatry ; 11: 203, 2011 Dec 28.
Artículo en Inglés | MEDLINE | ID: mdl-22204569

RESUMEN

BACKGROUND: To fully assess the various dimensions affected by schizophrenia, clinical trials often include multiple scales measuring various symptom profiles, cognition, quality of life, subjective well-being, and functional impairment. In this exploratory study, we characterized the relationships among six clinical, functional, cognitive, and quality-of-life measures, identifying a parsimonious set of measurements. METHODS: We used baseline data from a randomized, multicenter study of patients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder who were experiencing an acute symptom exacerbation (n = 628) to examine the relationship among several outcome measures. These measures included the Positive and Negative Syndrome Scale (PANSS), Montgomery-Asberg Depression Rating Scale (MADRS), Brief Assessment of Cognition in Schizophrenia Symbol Coding Test, Subjective Well-being Under Neuroleptics Scale Short Form (SWN-K), Schizophrenia Objective Functioning Instrument (SOFI), and Quality of Life Scale (QLS). Three analytic approaches were used: 1) path analysis; 2) factor analysis; and 3) categorical latent variable analysis. In the optimal path model, the SWN-K was selected as the final outcome, while the SOFI mediated the effect of the exogenous variables (PANSS, MADRS) on the QLS. RESULTS: The overall model explained 47% of variance in QLS and 17% of the variance in SOFI, but only 15% in SWN-K. Factor analysis suggested four factors: "Functioning," "Daily Living," "Depression," and "Psychopathology." A strong positive correlation was observed between the SOFI and QLS (r = 0.669), and both the QLS and SOFI loaded on the "Functioning" factor, suggesting redundancy between these scales. The measurement profiles from the categorical latent variable analysis showed significant variation in functioning and quality of life despite similar levels of psychopathology. CONCLUSIONS: Researchers should consider collecting PANSS, SOFI, and SWN-K in their trials. This would allow a broad spectrum of assessments that would have the ability to capture a wide range of treatment outcomes and allow for a rich characterization of the subgroups involved. Additional research is needed to identify the critical cognitive measures. CLINICAL TRIALS REGISTRATION: Predicting Response to Risperidone Treatment Through Identification of Early-onset of Antipsychotic Drug Action in SchizophreniaClinicalTrials.gov identifier: NCT00337662; http://www.clinicaltrials.gov/


Asunto(s)
Escalas de Valoración Psiquiátrica , Trastornos Psicóticos , Esquizofrenia , Psicología del Esquizofrénico , Estadística como Asunto , Adulto , Anciano , Análisis Factorial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Resultado del Tratamiento
17.
Soc Psychiatry Psychiatr Epidemiol ; 46(2): 159-65, 2011 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-20119828

RESUMEN

BACKGROUND: Relatively few studies have examined how patients with schizophrenia and depression view psychiatric research and what influences their readiness to participate. METHODS: A total of 763 patients (48% schizophrenia, 52% depression) from 7 European countries were examined using a specifically designed self-report questionnaire ["Hamburg Attitudes to Psychiatric Research Questionnaire" (HAPRQ)]. RESULTS: Most patients (98%) approved of psychiatric research, in general, at least "a little". There was a tendency to approve psychosocial rather than biological research topics (e.g. research on the role of the family by 91% of patients compared to 79% in genetics). Reasons to participate were mainly altruistic. Only a minority (28%) considered monetary incentives important. Patients wanted extensive background information and a feedback of the results; both were significantly more expressed by schizophrenia as compared to depressive patients, although these findings need to be interpreted with care because of age and gender differences between the diagnostic groups. CONCLUSION: While patients expressed discerning views of psychiatric research, only few differences were apparent between the two diagnostic groups. Patients' research priorities are not the same as those of many professionals and funding bodies. Their demonstrated critical appraisal should inform future research ensuring an increased patient role in the research process.


Asunto(s)
Actitud Frente a la Salud , Trastorno Depresivo/psicología , Participación del Paciente , Sujetos de Investigación/psicología , Esquizofrenia/diagnóstico , Psicología del Esquizofrénico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Comparación Transcultural , Trastorno Depresivo/diagnóstico , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Motivación , Escalas de Valoración Psiquiátrica/estadística & datos numéricos , Encuestas y Cuestionarios
18.
J Clin Psychopharmacol ; 30(6): 726-31, 2010 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-21105273

RESUMEN

BACKGROUND: Linking of the Clinical Global Impression (CGI) Scale and the Positive and Negative Syndrome Scale (PANSS) was performed within a naturalistic sample. Furthermore, these linking results were compared with those derived from randomized controlled trials to examine if the baseline severity might influence the linking results. METHODS: Biweekly PANSS and CGI ratings were performed from admission to discharge in 398 schizophrenia patients treated within a naturalistic study. Equipercentile linking was performed using the statistical program, R 2.8.1. To evaluate how the naturalistic study design would influence linkage results, a so-called study sample was computed with patients of the naturalistic study fulfilling common inclusion criteria of randomized controlled trials (n = 199). Patients not fulfilling these criteria (less ill sample) and those fulfilling the criteria (study sample) were compared using confidence intervals. RESULTS: We found a considerable difference between the linking of the CGI severity score and the PANSS total score comparing the less ill sample and the study sample. Being considered "mildly ill" at admission in the less ill sample corresponded to a PANSS total score of 47 points and to a PANSS total score of 67 points in the study sample. Considering the linking of the CGI improvement score and PANSS changes, similar results were found for CGI improvement ratings ranging from "very much improved" to "minimally improved". CONCLUSIONS: Despite considerable differences, a 50% PANSS reduction was found to correspond to a clinical rating of much improved, which seems to be a suitable definition for response in clinical drug trials.


Asunto(s)
Escalas de Valoración Psiquiátrica/estadística & datos numéricos , Esquizofrenia/fisiopatología , Índice de Severidad de la Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Esquizofrenia/terapia , Psicología del Esquizofrénico
19.
Psychopathology ; 43(2): 110-20, 2010.
Artículo en Inglés | MEDLINE | ID: mdl-20110763

RESUMEN

BACKGROUND/AIMS: There is growing evidence that the validity of diagnostic methods for personality disorders (PD) may be insufficient. Although the ICD-10 classification system is widely used, there is little data concerning its validity for diagnosing PD. METHODS: To examine convergent and discriminant validity of ICD-10 PD, corresponding dimensions were calculated using the Inventory of Clinical Personality Accentuations (self-rating) and the International Personality Disorder Examination ICD-10 module (interview and screening questionnaire). These were administered to 42 psychiatric patients. A multitrait-multimethod analysis of the 2 self-administered questionnaires and the structured interview was conducted. RESULTS: Correspondence between methods is significant at the level of 0.01 for the schizoid, borderline, anankastic, anxious and dependent PD dimensions. The investigation of discriminant validity within and between instruments reveals several strong relationships between different PD dimensions. CONCLUSION: Convergent validity can be considered sufficient for 5 of the 9 examined PD dimensions. Non-convergence must partly be interpreted as caused by poor discriminant validity inherent in the ICD-10 classification. Conceptualization of PD as completely distinguishable entities may not reflect the clinical reality of a partial overlap between personality disorders.


Asunto(s)
Clasificación Internacional de Enfermedades , Entrevista Psicológica , Trastornos de la Personalidad/diagnóstico , Inventario de Personalidad/estadística & datos numéricos , Adulto , Comorbilidad , Femenino , Humanos , Masculino , Trastornos Mentales/diagnóstico , Trastornos Mentales/psicología , Persona de Mediana Edad , Trastornos de la Personalidad/psicología , Psicometría/estadística & datos numéricos , Reproducibilidad de los Resultados , Adulto Joven
20.
Dialogues Clin Neurosci ; 12(2): 209-20, 2010.
Artículo en Inglés | MEDLINE | ID: mdl-20623925

RESUMEN

Despite advances in the understanding and treatment of obsessive-compulsive disorder (OCD), many patients undergoing interventions display incomplete symptom reduction, Our research group has developed a self-help manual entitled "My Metacognitive Training for OCD" (myMCT) aimed at raising patients' awareness about cognitive biases that seem to subserve OCD. The training is particularly intended for patients currently unable or unwilling to attend standard therapy, or in cases where such a treatment option is not available. For the present study, 86 individuals suffering from OCD were recruited over the Internet. Following the initial assessment, participants were either immediately emailed the myMCT manual or allocated to a waitlist group. After 4 weeks, a second assessment was performed, The myMCT group showed significantly greater improvement for OCD symptoms according to the Y-BOCS total score compared with the waitlist group (d = .63), particularly for obsessions (d= .69). Medium to strong differences emerged for the OCI-R (d = .70) and the BDI-SF (d = .50). The investigation provides the first evidence for the effectiveness of the myMCT for OCD.


Asunto(s)
Terapia Cognitivo-Conductual/métodos , Trastorno Obsesivo Compulsivo/terapia , Calidad de Vida/psicología , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Escalas de Valoración Psiquiátrica , Psicometría/métodos , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Resultado del Tratamiento
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