Observational Retrospective Study in Patients Treated with Galcanezumab as Preventive Treatment for Migraine: The ORYGAM Study.

Introduction: The efficacy of galcanezumab has been demonstrated in randomized controlled trials, but evidence about its use under clinical practice conditions is still limited. This study aimed to describe the characteristics of the patients treated with galcanezumab in routine clinical practice in Spain as well as treatment patterns, persistence, and effectiveness.

Methods: A retrospective chart review study was carried out in six hospitals.

Burden and Unmet Needs in Migraine Patients: Results from the OVERCOME (Spain) Study.

Introduction: This analysis aimed to evaluate demographics, migraine-related disability, symptoms, diagnosis and healthcare consultation, work productivity, and treatment patterns according to headache frequency in adults with migraine in the OVERCOME (ObserVational survey of the Epidemiology, tReatment and Care Of MigrainE) (Spain) study.

Methods: Data were obtained from an observational, cross-sectional, web-based survey conducted between October 2020-February 2021 in Spain. Eligible participants were adult members of online survey panels living in Spain who were able to read and write Spanish and fulfilled the International Classification of Headache Disorders, third edition (ICHD-3) criteria for migraine or had a self-reported physician diagnosis.

Adaptation and Validation of the Spanish Version of Decisional Conflict Scale in People with Migraine in Spain.

Purpose: We aimed to validate the Spanish version of the Decisional Conflict Scale (DCS) and analyze its psychometric properties in people with migraine.

Patients And Methods: The DCS validation comprised two phases. First, a translation and cross-cultural adaptation following the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practices: 1-preparation, 2-independent forward translation, 3-reconciliation, 4-back-translation, 5-harmonization, 6-clinical review, and 7-content validation in a group of migraine patients.

Persistence, use of resources and costs in patients under migraine preventive treatment: the PERSEC study.

Background: Migraine represents a serious burden for national health systems. However, preventive treatment is not optimally applied to reduce the severity and frequency of headache attacks and the related expenses. Our aim was to assess the persistence to traditional migraine prophylaxis available in Spain and its relationship with the healthcare resource use (HRU) and costs.

The MOPEAD project: Advancing patient engagement for the detection of "hidden" undiagnosed cases of Alzheimer's disease in the community.

In most, if not all health systems, dementia is underdiagnosed, and when diagnosis occurs, it is typically at a relatively late stage in the disease process despite mounting evidence showing that a timely diagnosis would result in numerous benefits for patients, families, and society. Moving toward earlier diagnoses in Alzheimer's disease (AD) requires a conscientious and collective effort to implement a global strategy addressing the multiple causes hindering patient engagement at different levels of society. This article describes the design of the Models of Patient Engagement for Alzheimer's Disease project, an ongoing EU-funded public-private multinational initiative that will compare four innovative patient engagement strategies across five European countries regarding their ability to identify individuals with prodromal AD and mild AD dementia, which are "hidden" in their communities and traditionally not found in the typical memory clinic setting.

Costs and quality of life in community-dwelling patients with Alzheimer's disease in Spain: results from the GERAS II observational study.

Background: Country-specific data on resource use and costs associated with Alzheimer's disease (AD) help inform governments about the increasing need for medical and financial support as the disease increases in prevalence.

Methods: GERAS II, a prospective observational study, assessed resource use, costs, and health-related quality of life (HRQoL) among patients with AD and their caregivers in Spain. Community-dwelling patients aged ≥55 years with probable AD, and their primary caregivers, were recruited by study investigators during routine clinical practice and assessed as having mild, moderate, or moderately severe/severe (MS/S) AD dementia based on patient Mini-Mental State Examination scores.

Broader conceptualization of remission assessed by the remission from depression questionnaire and its association with symptomatic remission: a prospective, multicenter, observational study.

Background: Goals of treating major depressive disorder (MDD) include achieving remission and avoiding relapse. It is possible that patients may have a broader view of remission than what is captured via clinician-rated scales. This patient perspective may, in turn, have an impact on treatment outcomes.

Switching to olanzapine long-acting injection from either oral olanzapine or any other antipsychotic: comparative post hoc analyses.

Background: A considerable proportion of patients suffering from schizophrenia show suboptimal responses to oral antipsychotics due to inadequate adherence. Hence, they are likely to benefit from switching to a long-acting injectable formulation. These post hoc analyses assessed the clinical effects of switching to olanzapine long-acting injection (OLAI) from either oral olanzapine (OLZ) or other antipsychotics (non-OLZ).

Systematic review of the economic aspects of nonadherence to antipsychotic medication in patients with schizophrenia.

Purpose: There is strong evidence supporting the link between nonadherence to antipsychotic medication and relapse of schizophrenia. However, less obvious are the economic consequences of nonadherence. The systematic review reported here evaluated the economic aspects of nonadherence to antipsychotic medication.

Residual symptoms and functioning in depression, does the type of residual symptom matter? A post-hoc analysis.

Background: The degrees to which residual symptoms in major depressive disorder (MDD) adversely affect patient functioning is not known. This post-hoc analysis explored the association between different residual symptoms and patient functioning.

Methods: Patients with MDD who responded (≥50% on the 17-item Hamilton Rating Scale for Depression; HAMD-17) after 3 months of treatment (624/930) were included.

Treatment patterns and health care resource utilization in a 1-year observational cohort study of outpatients with schizophrenia at risk of nonadherence treated with long-acting injectable antipsychotics.

Purpose: To describe (1) the clinical profiles and the patterns of use of long-acting injectable (LAI) antipsychotics in patients with schizophrenia at risk of nonadherence with oral antipsychotics, and in those who started treatment with LAI antipsychotics, (2) health care resource utilization and associated costs.

Patients And Methods: A total of 597 outpatients with schizophrenia at risk of nonadherence, according to the psychiatrist's clinical judgment, were recruited at 59 centers in a noninterventional prospective observational study of 1-year follow-up when their treatment was modified. In a post hoc analysis, the profiles of patients starting LAI or continuing with oral antipsychotics were described, and descriptive analyses of treatments, health resource utilization, and direct costs were performed in those who started an LAI antipsychotic.

Relapse and therapeutic interventions in a 1-year observational cohort study of nonadherent outpatients with schizophrenia.

Objectives: To evaluate the incidence rate of relapse, the clinical profiles, and the therapeutic interventions employed for patients with schizophrenia deemed as likely nonadherers to oral antipsychotic drugs.

Methods: A cohort of 597 outpatients whose therapy was modified because of a psychiatrist-perceived risk of nonadherence was followed for 12 months in an observational study. Baseline correlates of subsequent relapse were analyzed with Cox regression.

Early response and remission as predictors of a good outcome of a major depressive episode at 12-month follow-up: a prospective, longitudinal, observational study.

Objective: The goal of treating major depressive disorder (MDD) should be not only achieving remission in a particular episode but also avoiding relapses and attaining long-term recovery. The current study was designed to evaluate whether response and remission achieved within the first 6 weeks of antidepressant treatment are associated with a 12-month good outcome (achieving remission by 6 months and remaining in remission until the end of follow-up).

Method: This prospective, longitudinal, multicenter study included adult outpatients who had a DSM-IV diagnosis of MDD, baseline scores ≥ 15 on the 17-item Hamilton Depression Rating Scale (HDRS(17)), Clinical Global Impressions-Severity of Illness scores ≥ 4, and a minimum remission period of 12 weeks between the index episode and the immediately prior episode (or who were in their first MDD episode).

Clinical meaningful outcomes in schizophrenia: remission and recovery.

The traditional view of schizophrenia as a disabling and irremediably progressive disease is being reconsidered because of the evidences arising from long-term follow-up studies. On the other hand, recent advances of therapies have yielded significant functional improvements for some patients. Together, these facts are serving to raise treatment prospects, placing the focus on functional recovery.

Recovery from schizophrenia: results from a 1-year follow-up observational study of patients in symptomatic remission.

Objectives: This report presents the results of an observational empirical clinical investigation about the prevalence and correlates of a proposed definition of recovery from schizophrenia in outpatients in Spain.

Methods: Of 1010 outpatients with schizophrenia (DSM-IV-TR), a subgroup of 452 patients in symptomatic remission (SR) was followed for 1 year. SR was defined according to Andreasen's severity criteria based on the Scales for the Assessment of Positive (SAPS) and Negative (SANS) Symptoms.

Remission in schizophrenia: results from a 1-year follow-up observational study.

Objectives: This study used the Remission in Schizophrenia Working Group operational-severity criteria to, a) provide descriptive data on prevalence and stability of symptomatic remission, b) attempt a criterion (concurrent) validation of this measure of remission, and c) explore correlates of remission stability.

Methods: From an unselected sample of 1010 stable outpatients with schizophrenia (DSM-IV-TR), a subgroup of 452 (44.8%) in symptomatic remission was followed for 1 year.

Olanzapine orally disintegrating tablet: a review of efficacy and compliance.

Medication nonadherence, especially in psychiatric disorders, has been associated with treatment failure and other negative outcomes. Orally disintegrating formulations have been developed as an alternative to improve medication adherence. This report reviews the properties, efficacy, and safety profile of olanzapine as an orally disintegrating tablet, and explores their association with medication compliance compared with standard oral formulation.

Measuring schizophrenia remission in clinical practice.

Objective: To evaluate reliability and validity of the short forms (SF) assessment of positive (SAPS) and negative (SANS) symptoms scales.

Methods: In 235 Spanish schizophrenia outpatients, accuracy of the SF for measuring clinical remission (for at least 6 months) was assessed in comparison with the standard forms.

Results: For the SF overall score, Cronbach's alpha was 0.

The Schizophrenia Outpatient Health Outcomes (SOHO) study: 3-year results of antipsychotic treatment discontinuation and related clinical factors in Spain.

Introduction: This article presents the long-term results in terms of antipsychotic medication maintenance and factors influencing it in a representative sample of patients with schizophrenia recruited in the SOHO study within Spain.

Methods: The SOHO was a prospective, 3-year observational study of the outcomes of schizophrenia treatment in outpatients who initiated therapy or changed to a new antipsychotic performed in 10 European countries with a focus on olanzapine. The Kaplan-Meier method was used to analyse the time to treatment discontinuation and the Cox proportional hazards model to investigate correlates of discontinuation.

Symptomatic remission and social/vocational functioning in outpatients with schizophrenia: prevalence and associations in a cross-sectional study.

Purpose: Progress in therapeutic options for schizophrenia has revived long-term expectations of researchers, practitioners and patients. At present, definitions of therapeutic outcome include both maintained symptomatic remission and appropriate functioning in a conceptual framework that targets patient's recovery as the ultimate goal. We aimed to know the prevalence and clinical features of patients with schizophrenia achieving these outcomes.

Effect of olanzapine or risperidone treatment on some cognitive functions in a one-year follow-up of schizophrenia outpatients with prominent negative symptoms.

Aims: To compare olanzapine and risperidone outcome on some neurocognitive dimensions in chronic schizophrenia patients with prominent negative symptoms.

Method: We randomised and followed for 1 year 235 chronic schizophrenia outpatients with a SANS global score > or =10 to open-label flexible-dose treatment with olanzapine or risperidone. Clinical, functional and cognitive assessments [including the COGLAB battery reaction time, vigilance-span of apprehension (VSA) and a card-sorting task] were done periodically.

Improvement in social functioning in outpatients with schizophrenia with prominent negative symptoms treated with olanzapine or risperidone in a 1 year randomized, open-label trial.

Unlabelled: GENERAL PURPOSE: To evaluate the social functioning of schizophrenic outpatients after switching to second-generation antipsychotics.

Methodology: Multi-center, randomized, open-label, parallel, flexible-dose, 1-year study of schizophrenic outpatients with prominent negative symptoms (defined as a SANS Global score > or =10), previously treated with conventional antipsychotics. Patients were randomly assigned (1:1 ratio) to treatment with an initial dose of at least 10 mg/day olanzapine (N = 120) or at least 3 mg/day risperidone (N = 115).

A randomized, 1-year follow-up study of olanzapine and risperidone in the treatment of negative symptoms in outpatients with schizophrenia.

Objective: To evaluate the efficacy of olanzapine compared with risperidone in negative symptoms, after 1 year of treatment, in schizophrenic outpatients with prominent negative symptoms.

Methods: This was a multicenter, randomized, monitored, open-label, parallel, dose-flexible, 1-year study of outpatients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) with prominent negative symptoms (Scale for the Assessment of Negative Symptoms [SANS] summary score > or =10) previously treated with conventional antipsychotics. Patients were randomly assigned to treatment with an initial dose of olanzapine 10 mg/d or more (n = 120) or risperidone 3 mg/d or more (n = 115).

Safety and effectiveness of olanzapine in monotherapy: a multivariate analysis of a naturalistic study.

Background: This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia.

Method: This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S).

Safety, effectiveness, and patterns of use of olanzapine in acute schizophrenia: a multivariate analysis of a large naturalistic study in the hospital setting.

Background And Objective: This study assessed the safety and effectiveness of the atypical antipsychotic olanzapine for the treatment of inpatients with acute schizophrenia. Furthermore, we evaluated patterns of use of olanzapine and their relationship to safety and effectiveness.

Patients And Method: This was a prospective, comparative, nonrandomized, open-label, observational study of 848 patients with schizophrenia (International Classification of Diseases, 10th edition) hospitalized due to an acute psychotic episode.