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BACKGROUND: Bilastine is a second-generation antihistamine for the symptomatic treatment of allergic rhinoconjunctivitis (ARC) and urticaria in adults, adolescents, and children. The pharmacokinetics and safety of oral bilastine 10 mg/d in children aged 2 to 5 years were evaluated. METHODS: This was a multicenter, open-label clinical trial in children aged 2 to 5 years with seasonal or perennial ARC or urticaria treated once daily with bilastine 10 mg orodispersible tablets. The safety evaluation included treatment-emergent adverse events (TEAEs), vital signs, and physical examination. Pharmacokinetic data were pooled with data from a prior pediatric study, and pharmacokinetic modeling was performed to assess consistency. RESULTS: A total of 37 children with ARC (81.1%), urticaria (8.1%), or both (10.8%) were included in the study, with a mean (SD) age of 3.7 (1.2) years. The highest plasma concentrations of bilastine were observed 1 hour after administration (634.91 ng/mL). Eight patients (21.6%) experienced 1 TEAE each, none of which was severe. Body weight and age were not covariates of variation in either systemic clearance or the volume of distribution in children aged 2 to 5 years and did not affect the pharmacokinetic parameters of bilastine. CONCLUSIONS: The pharmacokinetics of bilastine was linear and consistent with data from a previous trial, suggesting that a 10-mg dose may be used in children (2 to <12 years). No dose adjustments are deemed necessary. Oral once-daily bilastine 10 mg presented a good safety profile in children aged 2 to 5.
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INTRODUCTION: DISCERN is an instrument designed to help patients assess the reliability of written information on treatment choices. Originally created in English, there is no validated Spanish version of this instrument. This study seeks to validate the Spanish translation of the DISCERN instrument used as a primary measure on a multicenter study aimed to assess the reliability of web-based information on treatment choices for attention deficit/hyperactivity disorder (ADHD). METHODS: We used a modified version of a method for validating translated instruments in which the original source-language version is formally compared with the back-translated source-language version. Each item was ranked in terms of comparability of language, similarity of interpretability, and degree of understandability. Responses used Likert scales ranging from 1 to 7, where 1 indicates the best interpretability, language and understandability, and 7 indicates the worst. Assessments were performed by 20 raters fluent in the source language. RESULTS: The Spanish translation of DISCERN, based on ratings of comparability, interpretability and degree of understandability (mean score (SD): 1.8 (1.1), 1.4 (0.9) and 1.6 (1.1), respectively), was considered extremely comparable. All items received a score of less than three, therefore no further revision of the translation was needed. CONCLUSION: The validation process showed that the quality of DISCERN translation was high, validating the comparable language of the tool translated on assessing written information on treatment choices for ADHD.
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Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Pautas de la Práctica en Medicina/estadística & datos numéricos , Escritura , Comunicación , Toma de Decisiones , Humanos , Internet , Lenguaje , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: A cascade of events follows initial antidepressant selection which includes the subsequent antidepressant use pattern, resultant clinical outcomes, and associated health care expenditures. PURPOSE: The purpose of this study using data from a clinical practice setting was to test whether the pattern of antidepressant use was correlated with patients' treatment response as measured by the score on the Clinical Global Impression-Improvement scale. DATA AND METHODS: A retrospective dataset of patients who initiated therapy on fluoxetine, fluvoxamine, paroxetine, or sertraline in a primary care setting in Spain was used. A Cox proportional hazard analysis was used to predict the likelihood of treatment response based upon the pattern of initial antidepressant use, while minimizing the influence of other factors. RESULTS: After controlling for other observed baseline characteristics including initial disease severity, (a) patients who remained on their initial antidepressant therapy for at least 2 months with no switching, augmentation, or upward dose titration were 1.63 times more likely to experience a treatment response than patients who had an adjustment to therapy; and (b) patients who initiated therapy on sertraline were 0.46 times as likely to experience a treatment response as patients who initiated therapy on the most common study antidepressant, fluoxetine. CONCLUSION: The pattern of antidepressant use is an important determinant of treatment response among patients initiating therapy on the newer antidepressants in clinical practice.
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Trastorno Depresivo/tratamiento farmacológico , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Adulto , Trastorno Depresivo/diagnóstico , Trastorno Depresivo/psicología , Relación Dosis-Respuesta a Droga , Femenino , Estudios de Seguimiento , Costos de la Atención en Salud , Humanos , Masculino , Escalas de Valoración Psiquiátrica , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: The simultaneous presentation of both manic and depressive symptoms has long been recognized. Nevertheless, a variable prevalence of dysphoric mania has been reported. The aim of this study was to estimate the prevalence of dysphoric mania among hospitalized patients and to assess the effectiveness of olanzapine in this type of patients. METHODS: Eighty-six patients who met DSM-IV criteria for mania were evaluated at admission with a protocol that included McElroy's criteria for dysphoric mania [Am. J. Psychiatry 149 (1992) 1633]. Treatment was administered according to clinical need, using mood stabilizers combined with antipsychotics. Sequential assessments were conducted throughout the study. RESULTS: Forty-four patients (51.2%) fulfilled McElroy's criteria for dysphoric mania. Fourteen of these dysphoric patients were treated with olanzapine in combination with mood-stabilizers. All patients improved in manic symptoms but patients treated with olanzapine improved significantly more than those treated with other antipsychotics in depressive symptoms. LIMITATIONS: The lack of randomization is a methodological limitation of this study, so these findings should be considered as preliminary. CONCLUSIONS: Dysphoric symptoms are common in this population of manic patients. Olanzapine in combination with mood-stabilizers may be effective in these patients. Additional controlled studies are needed to replicate these results.
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Antipsicóticos/uso terapéutico , Trastorno Bipolar/tratamiento farmacológico , Pirenzepina/análogos & derivados , Pirenzepina/uso terapéutico , Adulto , Antimaníacos/efectos adversos , Antimaníacos/uso terapéutico , Antipsicóticos/efectos adversos , Benzodiazepinas , Trastorno Bipolar/diagnóstico , Trastorno Bipolar/psicología , Quimioterapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Examen Neurológico/efectos de los fármacos , Olanzapina , Pirenzepina/efectos adversos , Escalas de Valoración Psiquiátrica , Resultado del TratamientoRESUMEN
Some preliminary studies have suggested that the beta-adrenoceptor 5-HT1A antagonist pindolol (PIN) could increase the effect of selective serotonin reuptake inhibitors (SSRIs). We prospectively estimated the cost-effectiveness of fluoxetine and pindolol versus fluoxetine plus placebo, using results from the first double-blind randomized clinical trial comparing both treatments. Efficacy and medical care resource utilization were collected prospectively in a parallel, randomized, double-blind clinical trial conducted in a single centre in Spain. Average cost-effectiveness (cost/% response and cost/% remission) as well as the incremental cost-effectiveness were calculated for both treatments. A 'bootstrap' method was used to calculate confidence limits around the incremental cost-effectiveness ratio. A significantly greater percentage of patients (one-tailed P < 0.05) in the fluoxetine FLX + PIN group than in the FLX + PLA group had experienced a therapeutic response (74.5% versus 58.97%) at 6 weeks. Direct medical costs were lower in the FLX + PIN group (mean 2508 pesetas per patient) than in the FLX + PLA group (mean 31870 pesetas per patient). Hospital admissions due to worsening of depressive symptoms were significantly lower (P < 0.05) in the FLX + PIN group (0/55) than in the FLX + PLA group (4/56). The observed differences in average costs and percentage response in the study were -29362 pesetas (< 0) and 15.6% (> 0), respectively, and the resulting cost-effectiveness ratio was negative. These outcomes indicate that the FLX + PIN option completely dominates FLX + PLA. These results suggest that, over a course of 6 weeks of treatment, the combination of fluoxetine and pindolol incurs lower direct medical costs than treatment with fluoxetine placebo. Despite their limitations, economic assessments in addition to clinical trials allow a 'dynamic assessment' on the potential success of the drug, both from a clinical and an economic point of view, allowing decisions on priorities to be made earlier.
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Antidepresivos de Segunda Generación/economía , Trastorno Depresivo/tratamiento farmacológico , Fluoxetina/economía , Pindolol/economía , Antagonistas de la Serotonina/economía , Adulto , Antidepresivos de Segunda Generación/uso terapéutico , Análisis Costo-Beneficio , Trastorno Depresivo/economía , Método Doble Ciego , Quimioterapia Combinada , Femenino , Fluoxetina/uso terapéutico , Costos de la Atención en Salud/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Pindolol/uso terapéutico , Antagonistas de la Serotonina/uso terapéuticoRESUMEN
BACKGROUND: Several post-hoc studies have shown that lack of early improvement reduces the chance of later response or remission. This post-hoc analysis evaluates different cut-off points of non-improvement at 4 weeks of escitalopram treatment to predict 8-week non-response and non-remission. METHOD: This study consisted of MDD patients with an absence of improvement (<30% reduction in baseline score of the HAMD-17) at Week 4 of escitalopram treatment (10mg/day) that continued escitalopram treatment (10-20mg/day) for a further 4-week period (n=251). Predictive, sensitivity and specificity values for the several definitions of non-improvement (≤ 25%, ≤ 20% and ≤ 15% reduction in the HAMD-17 baseline total score) at 4 weeks were calculated. RESULTS: Overall, 70.1% (176/251) of patients did not achieve response at Week 8 and 84.5% (212/251) did not achieve remission. The predictive value for non-response was high (71.4-74.3%) for all cut-off points of non-improvement tested. The respective values for non-remission were placed between 85.0% and 87.2%. LIMITATIONS: This was a post-hoc subgroup analysis. The only drug assessed was escitalopram. CONCLUSIONS: Our data indicate that an absence of improvement, <30% reduction in the HAMD-17, after 4 weeks of escitalopram treatment should prompt clinicians to consider a change in treatment strategy. Similar findings were previously reported for other antidepressants.
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Antidepresivos/uso terapéutico , Citalopram/uso terapéutico , Trastorno Depresivo Mayor/tratamiento farmacológico , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Pronóstico , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: To evaluate social and occupational functioning in patients in partial remission (PR) compared with patients in complete remission (CR) of a major depressive disorder (MDD) episode. SUBJECTS AND METHODS: This is a six-month prospective study. PR was defined as a score more than 7 and less or equal to 15 in the Hamilton Depression Rating Scale, and CR as less or equal to 7. All patients had been on acute antidepressant treatment during the previous three months and no longer met criteria for MDD. Functioning was assessed by the Social and Occupational Functioning Assessment Scale (SOFAS). RESULTS: Mean (S.D.) patient age was 50.5 (14.5) years (N=292) and 77% were female. At baseline, partial remitters showed greater impairment in social and occupational functioning than complete remitters (62.8 [12.6] versus 80.4 [10.5], respectively; P<.0001). After six months, only 47% PR versus 77% CR reached normal functioning, and SOFAS ratings for PR were below normal range (76.2 [12.3] PR versus 84.6 [9.4] CR; P<.0001). PR reported three times more days absent from work due to sickness than CR (63 days versus 20 days; P<.001). CONCLUSION: We conclude that PR of an MDD episode is associated with significant functional impairment that persists even after nine months of antidepressant treatment. Our results underline the importance of treating the patient until achieving full remission.
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Trastorno Depresivo Mayor , Empleo/psicología , Empleo/estadística & datos numéricos , Conducta Social , Trastorno Depresivo Mayor/diagnóstico , Trastorno Depresivo Mayor/epidemiología , Trastorno Depresivo Mayor/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Inducción de Remisión , Encuestas y CuestionariosRESUMEN
BACKGROUND: Recent studies demonstrate that many Bipolar Disorder (BD) patients experience mild symptoms and/or suffer significant functional impairment during periods of syndromal remission, suggesting greater relapse risk and need for more intensive therapeutic strategies. However, most studies have cross-sectional designs and other methodological limitations. This study aimed to prospectively evaluate whether the presence of subsyndromal symptoms and level of functionality have long-term consequences in BD patients in syndromal remission. METHODS: A 1-year, prospective, observational cohort study of BD patients in syndromal remission assessed participants at study entry and 3, 6 and 12months after baseline on a range of clinical, social and functional outcomes. RESULTS: A total of 473 BD patients were screened at 51 study sites across Spain. Finally, 398 patients with bipolar I disorder in syndromal remission were included. After the 12-month, follow-up period, 87.6% of patients remained in syndromal remission, 79.9% of patients were free of subsyndromal symptoms, but only 53.5% had normal levels of functionality. Patients without subsyndromal symptoms and with normal levels of functionality at baseline had longer time to relapse, lower relapse risk, fewer changes on medication and hospitalizations, better employment, less medical/psychiatric leaves and better functional household membership. LIMITATIONS: Limitations of this study are related with its naturalistic design. CONCLUSIONS: In a prospectively assessed BD cohort with all patients in syndromal remission at baseline, syndromal remission was not always accompanied by normal functioning and/or the presence subsyndromal symptoms. Interventions, including medication and psychosocial approaches, should go beyond syndromal remission and target subsyndromal symptoms and functional recovery.
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Trastorno Bipolar/diagnóstico , Trastorno Bipolar/psicología , Adaptación Psicológica , Adulto , Antimaníacos/uso terapéutico , Trastorno Bipolar/tratamiento farmacológico , Estudios de Cohortes , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Femenino , Estudios de Seguimiento , Humanos , Entrevista Psicológica , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Psicotrópicos/uso terapéutico , Recurrencia , Ajuste Social , SíndromeAsunto(s)
Traumatismos Craneocerebrales/complicaciones , Pimozida/uso terapéutico , Agitación Psicomotora/tratamiento farmacológico , Trastornos Psicóticos/tratamiento farmacológico , Trastornos Puerperales/tratamiento farmacológico , Adulto , Femenino , Humanos , Masculino , Agitación Psicomotora/etiología , Trastornos Psicóticos/psicología , Trastornos Puerperales/psicologíaAsunto(s)
Trastorno Autístico/psicología , Trastornos de la Conducta Infantil/tratamiento farmacológico , Trastornos de la Conducta Infantil/etiología , Fluoxetina/uso terapéutico , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Niño , Trastornos de la Conducta Infantil/diagnóstico , Preescolar , Femenino , Humanos , Masculino , Índice de Severidad de la EnfermedadAsunto(s)
Delirio por Abstinencia Alcohólica/tratamiento farmacológico , Ansiolíticos/uso terapéutico , Clorpromazina/administración & dosificación , Meperidina/administración & dosificación , Prometazina/administración & dosificación , Psicosis Alcohólicas/tratamiento farmacológico , Adulto , Clorazepato Dipotásico/uso terapéutico , Combinación de Medicamentos , Resistencia a Medicamentos , Humanos , Inyecciones Intramusculares , MasculinoRESUMEN
INTRODUCTION: The Social Functioning Scale (SFS) was designed to evaluate social functioning essential to schizophrenic patients. Its length may be difficult to use in clinical practice. The objective of this study was to develop and validate a short version of the SFS. METHODS: Data from 445 patients with schizophrenia who came from two separate studies, one longitudinal (n=250) and one cross-sectional (n=195), were used to produce and validate the short form of the SFS. The two samples were combined and then randomly split into two subsamples. In the first subsample (n = 223), items were eliminated using classical, modern (item response theory) psychometric criteria, as well as clinimetric criteria. The short version was independently validated using data from the other subsample (n = 222), by comparing the level of association (correlation and Area Under the ROC Curve [AUC]) with the EQ-5D VAS and the Clinical Global Impression (CGI), with the original scale. RESULTS: The original 78 items were reduced initially to 19 and 13 items (respectively using classic and modern psychometric criteria) and then to 15, since 2 items related with the employment capacity were added for clinometric criteria. The short form of the SFS had a Cronbach's alpha of 0.76. Spearman correlation coefficients with the EQ-5D VAS and with the CGI score (0.46 and 0.42, respectively) were similar or even higher for the short version than for the original version. The AUC of the SFS and the dichotomous CGI were practically the same for both the original (AUC: 0.74) and the short (AUC: 0.73) versions. CONCLUSIONS: The short version of the SFS proved to be reliable and valid. It could be adequate for use in clinical practice.
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Relaciones Interpersonales , Esquizofrenia , Psicología del Esquizofrénico , Encuestas y Cuestionarios , Adulto , Femenino , Humanos , Masculino , Reproducibilidad de los Resultados , Esquizofrenia/diagnósticoRESUMEN
INTRODUCTION: Three year data collected in the frame of the SOHO study within Spain were used to evaluate antipsychotic treatment outcomes by analyzing remission and relapse as well as the factors influencing them. METHODS: The SOHO was a prospective, long-term, observational study of the outcomes of schizophrenia treatment in ambulatoty who initiated therapy or who changed to a new antipsychotic drug performed in 10 European countries, with a focus on olanzapine. This article reports the attainment of international schizophrenia clinical remission and relapse criteria and the associated correlates in these patients. RESULTS AND CONCLUSIONS: A total of 2,020 patients were recruited in Spain. Almost 2/3 (60.1%) of the patients met the criteria for clinical remission. Factors that influence the likelihood of remission were identified, such as gender, baseline clinical and/or functional status, time since treatment initiation, treatment with olanzapine versus oral typical antipsychotics, duration of treatment, gender or the need for concomitant anxiolytics. Relapse occurred in 18.7% of patients. Treatment with quetiapine or the prescription of anticholinergics was associated with a greater risk of relapse. CONCLUSIONS: These results highlight some prognostic factors of the course of schizophrenia and underscore the importance of the antipsychotic choice and its maintenance to achieve favorable long-term clinical outcomes in routine practice.
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Atención Ambulatoria , Antipsicóticos/uso terapéutico , Benzodiazepinas/uso terapéutico , Esquizofrenia/terapia , Adulto , Femenino , Humanos , Masculino , Olanzapina , Estudios Prospectivos , Recurrencia , Inducción de Remisión , Esquizofrenia/tratamiento farmacológico , Factores de TiempoRESUMEN
INTRODUCTION: Attention-Deficit/Hyperactivity Disorder (ADHD) is associated with deterioration of several dimensions of quality of life (QoL) and with the development of comorbid psychiatric disorders. The objective of the present study is to evaluate the burden of illness of ADHD subtypes in untreated newly diagnosed children in Spain. METHODS: We recruited 124 children (80 combined, 25 inattentive and 19 hyperactive-impulsive subtype) aged 6-12 years with untreated newly diagnosed Diagnostic and Statistical Manual of Mental Disorders, 4th edition DSM-IV) ADHD. We collected socio-demographic, clinical (Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD-RS], Conner's Parent Rating Scale-Revised: Short Form [CPRS:R-S], Clinical Global Impression-Severity [CGI-S], Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version [K-SADS-PL], intelligence Quotient [IQ]), Quality of Life (QoL), Child Health Questionnaire-Parent Form 50 CHQ-PF50), academic performance and health care resources utilization data. We investigated the correlations between ADHD symptom severity and QoL, academic performance and time from onset of symptoms to diagnosis. RESULTS: QoL of children with combined-type ADHD was rated as significantly worse in patients with predominance of hyperactivity/impulsivity for most of the domains. Inattentive-type children also had worse ratings than patients with hyperactivity/impulsivity predominance in most of the domains. The ADHD Index of Conner's Parent Rating Scale-Revised: Short Form (CPRS-R:S) was significantly lower in hyperactive/impulsive patients. We found no differences across subtypes in IQ, academic performance and health care resources utilization. Higher ADHD symptom severity was associated to poor QoL. CONCLUSIONS: Combined and inattentive subtypes are associated with greater disorder severity, more comorbid psychiatric disorders, and worse QoL than the subtype with hyperactivity/impulsivity predominance.
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Trastorno por Déficit de Atención con Hiperactividad/clasificación , Costo de Enfermedad , Trastorno por Déficit de Atención con Hiperactividad/diagnóstico , Estudios de Casos y Controles , Niño , Femenino , Humanos , Masculino , Estudios Prospectivos , Calidad de Vida , Encuestas y CuestionariosRESUMEN
INTRODUCTION: Although treatment for mania has been studied extensively in randomized clinical trials, there are few data that address how these patients are truly managed in clinical, functional, and economic terms in the psychiatric practice in Spain. OBJECTIVE: To determine prescribing patterns in Spain on the basis of the Spanish sample of bipolar patients in manic or mixed phase included as part of the pan-European EMBLEM Study. METHOD: The EMBLEM Study recruited 3,681 patients, 312 of whom (8.47%) were included in Spain. Patients had to be adults with a diagnosis of bipolar disorder who were initiating treatment for a manic phase. They underwent evaluation using the Spanish versions of scales that measure severity of mania (the Young Mania Rating Scale, CGI-BP and the Hamilton Scale) and functional level (LCM, SLICE of LIFE). Information was collected regarding drug and treatment adherence variables. RESULTS: Prior to being admitted into the study, 42% of the patients were receiving polytherapy, 35% were on monotherapy, and 23% were not taking any medication whatsoever. Forty percent of the patients presented partial or total non-compliance with the treatment prescribed. During the first stage of the study, in the case of single-drug treatment, acute management for mania consisted of mean daily doses of 25 mg of olanzapine, 6.6 mg of risperidone, 9.5 mg of haloperidol, 165 mg of lamotrigine, 938.5 mg of valproate, and 909 mg of lithium, whereas when combined therapy was used, the following doses were used: olanzapine, 22.1 mg; risperidone, 7.3 mg; haloperidol, 12.3 mg; lamotrigine, 1,75.1 mg; valproate, 1,038.4 mg, and lithium, 1012.6 mg. Of those patients who were on monotherapy at the beginning of the study 51% were treated with a single drug, whereas 48% were receiving polytherapy. Among the participants who were receiving combined treatment when they began the study, almost all of them, 94%, were prescribed combined treatment. In the case of the hospitalized patients who made up 88% of the sample, the vast majority, 92%, had improved by the time the study was completed. Mean time to release from hospital was 24 days. DISCUSSION: In Spain, treatment for mania is essentially based on combined treatments, hospitalization, and antimania drugs that are prescribed at somewhat higher doses than those recommended in the corresponding prescribing information documents, which indicates that the clinical reality of this entity is far more complex than clinical trials conducted in experimental conditions suggest.
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Trastorno Bipolar/tratamiento farmacológico , Trastorno Bipolar/epidemiología , Quimioterapia/métodos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adulto , Quimioterapia/estadística & datos numéricos , Femenino , Humanos , Masculino , España/epidemiologíaRESUMEN
INTRODUCTION: Serotonergic dysfunction have been implicated in the pathophysiology of the autism. SRIs have shown efficacy in improving some symptoms in children with Autism. OBJECTIVES: To evaluate, in a pilot study, the efficacy and safety of fluoxetine in very young children with autism. METHOD: 1 year open-label trial was made with fluoxetine on 12 patients (3 to 13 years old) with Pervasive Developmental Disorder. CGI-severity was used to assess the severity and the improvement of symptoms. Individual symptoms improvement was assessed by both parents and therapists. Fluoxetine dose was titrated in all patients from 1.2 ml/day to reach a final doses of 3,6 or 5 ml/day in four weeks. Tolerance was assessed by collecting spontaneous adverse events. RESULTS: 11 children completed the study. Children experienced a moderate or marked improvement (final score in CGI 3 to 5). Communication and attention skills were improved. There were also a decrease of rituals, stereotypies and repetitive behaviours. Most common adverse events were increase of impulsivity and restlessness, other events were sleep disturbances and lost of appetite. 6 children needed concomitant medication with carbamacepine and 1 with levopromacine along the study. CONCLUSIONS: These results support that Fluoxetine at doses of 5 ml/day (20 mg/day) could help to improve some symptoms in Pervasive Developmental Disordersand allow to increase the effectiveness of therapies in these patients. More studies are needed to confirm these results.
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Trastorno Autístico/tratamiento farmacológico , Fluoxetina/uso terapéutico , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Adolescente , Niño , Preescolar , Femenino , Humanos , Masculino , Proyectos PilotoRESUMEN
In a controlled trial, the beta-adrenoceptor/5-hydroxytryptamine-1A (5-HT1A) receptor antagonist pindolol accelerated and enhanced the antidepressant effect of fluoxetine. The median times to sustained response (> or = 50% reduction of baseline severity maintained until endpoint) were 19 days for fluoxetine plus pindolol (N = 55) and 29 days for fluoxetine plus placebo (N = 56) (p = 0.01). The response rate at endpoint was 16% greater in patients treated with the combination. The plasma concentration of pindolol remained stable between 3 days (first blood sampling) and 6 weeks. Mean values were approximately 26 nM, a concentration higher than the Ki of (-)pindolol for human 5-HT1A autoreceptors (11 nM). Plasma fluoxetine and norfluoxetine concentrations increased steadily until the fourth week of treatment. Fluoxetine concentrations were lower in patients receiving the combination (p = 0.043), but there was no significant relationship to the clinical response in either group. A reanalysis of the data using a survival analysis revealed that significant differences in the time to sustained response between both groups would have also been detected (1) in a 2-week trial, (2) without a placebo lead-in phase, and (3) with less frequent visits. However, the use of "response" instead of "sustained response" as measure of clinically relevant change would have greatly diminished the difference between treatment arms (p = 0.08 instead of p = 0.01). This emphasizes the need of using stringent outcome criteria in antidepressant drug trials. A comparison of the data of all sustained responders (N = 27) in the fluoxetine-plus-placebo group with the first 27 responders in the fluoxetine-plus-pindolol group (of a total of 38) revealed a highly significant difference in the time to sustained response (18 and 10 days, respectively; p = 0.0002). This indicates that the faster response in the fluoxetine-plus-pindolol group is not a result of the greater proportion of responders.
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Antidepresivos/uso terapéutico , Trastorno Depresivo Mayor/tratamiento farmacológico , Fluoxetina/uso terapéutico , Pindolol/uso terapéutico , Antagonistas Adrenérgicos beta/efectos adversos , Antagonistas Adrenérgicos beta/farmacocinética , Antagonistas Adrenérgicos beta/uso terapéutico , Adulto , Antidepresivos/efectos adversos , Antidepresivos/farmacocinética , Trastorno Depresivo Mayor/metabolismo , Trastorno Depresivo Mayor/mortalidad , Método Doble Ciego , Quimioterapia Combinada , Femenino , Fluoxetina/efectos adversos , Fluoxetina/farmacocinética , Humanos , Masculino , Métodos , Pindolol/efectos adversos , Pindolol/farmacocinética , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: Major depression affects more than 5% of the population and is a serious health and economic problem. Antidepressants have a slow onset of action and are effective in less than two-thirds of patients. The biochemical effects of selective serotonin reuptake inhibitors may be limited by the negative feedback from serotonin autoreceptors. Pindolol is an antagonist of both serotonin autoreceptors and beta-adrenoceptors. We studied the effect of the addition of pindolol to fluoxetine antidepressant treatment. METHODS: Of 132 eligible patients with major depression, 111 were randomly assigned to treatment with fluoxetine (20 mg daily) and either placebo or pindolol (7.5 mg daily). Patients were assessed twice a week for the first 3 weeks of active treatment and then once a week until the end of the study (42 days). Hamilton and Montgomery-Asberg depression-rating scales were used to assess depression severity. FINDINGS: The proportion of patients who responded to treatment with fluoxetine and pindolol was greater than that with fluoxetine and placebo (41/55 [75%] vs 33/56 [59%], [90% CI 1.1-30.1], p = 0.04). The proportion of patients who achieved a sustained response was also greater in the fluoxetine and pindolol group than in the fluoxetine and placebo group (38/55 [69%] vs 27/56 [48%] [5.9-35.9], p = 0.03). The number of days to reach a sustained response was lower in the fluoxetine and pindolol group than in the fluoxetine and placebo group (median 19 vs 29 days, p = 0.01), however, there was no difference in the time-to-onset of clinical improvement when stringent conditions were used (15 vs 18 days, p = 0.20). INTERPRETATION: The addition of pindolol to fluoxetine antidepressant treatment increases the effectiveness of fluoxetine therapy. Further work is needed to resolve whether the time to clinical improvement benefits from this combination and whether the increase in efficacy occurs with other antidepressants.
Asunto(s)
Depresión/tratamiento farmacológico , Fluoxetina/uso terapéutico , Pindolol/uso terapéutico , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Adulto , Antidepresivos de Segunda Generación/administración & dosificación , Antidepresivos de Segunda Generación/uso terapéutico , Método Doble Ciego , Quimioterapia Combinada , Femenino , Fluoxetina/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Pindolol/administración & dosificación , Escalas de Valoración Psiquiátrica , Inhibidores Selectivos de la Recaptación de Serotonina/administración & dosificación , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION: Several investigations have communicated frequent association between alcohol dependence and depression. METHOD: 21 subjects with DSM-IV criteria for alcohol dependence were included in an open label trial for alcohol withdrawal. At inclusion and along the follow-up none of the probands met DSM-IV criteria for mood disorder. Follow-up included a 15-day detoxification period and 195 days of withdrawal program, including treatment with 20 mg/d of fluoxetine. Occurrence of depressive semiology was measured using the Beck Depression Inventory (BDI) on day 15 (after detoxification), day 75 and day 210 (after withdrawal from ethanol of 195 days). RESULTS: 67% of the sample showed a positive basal BDI (after-detoxification-BDI> 9). Global retention rate after 210 days of follow-up was 57%. All patients who dropped out the investigation before completing the protocol showed a basal BDI in the depressive rank (BDI= 10-63), and maintained depressive scores in this instrument until their abandonment. CONCLUSIONS: Prevalence of <
Asunto(s)
Alcoholismo/psicología , Trastorno Depresivo/diagnóstico , Síndrome de Abstinencia a Sustancias/diagnóstico , Adolescente , Adulto , Alcoholismo/diagnóstico , Áreas de Influencia de Salud , Trastorno Depresivo/tratamiento farmacológico , Trastorno Depresivo/epidemiología , Diagnóstico Diferencial , Femenino , Fluoxetina/uso terapéutico , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Escalas de Valoración Psiquiátrica , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Índice de Severidad de la Enfermedad , España , Síndrome de Abstinencia a Sustancias/psicología , SíndromeRESUMEN
INTRODUCTION: Data from naturalistic studies have reported differences in the clinical use of antidepressants referring to the need for adjusting doses, treatment duration, tolerability and use of concomitant medication. These differences could be considered as an indicator of the effectiveness of antidepressants in clinical practice settings. OBJECTIVES: It is a naturalistic, retrospective, observational study which objective is to evaluate and compare the pattern of antidepressant use (fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine) and to establish if there is a relation between the different pattern of use and the effectiveness of them. DATA AND METHODS: A retrospective dataset of patients who initiated therapy on fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine with a follow-up period of 6 months was used. Information about clinical characteristics of patients and antidepressant pattern of use were collected. Pattern of antidepressant use were defined as: "initial doses", "upward dose titration", "augmentation strategy", "switching" and "early interruption of treatment". The efficacy of the therapy was assessed by the CGI-improvement. RESULTS: Fluoxetine was the antidepressant more associated with a statistical significance (p = 0.001) to an stable pattern of use (initial doses without upward dose titration, switching or augmentation). After controlling for other observed baseline characteristics, patients who remained on their initial antidepressant therapy, with a stable pattern of use were 1.61 times more likely than patients who had an adjustment to therapy to experience a treatment response. Patients who initiated treatment with sertraline or venlafaxine were 2.155 and 4.831 times less likely, respectively, to experience a response relative to patients who initiated therapy on fluoxetine. CONCLUSIONS: The need to upward dose titration, switching or augmentation in the treatment could be indicated a worse therapeutic control of the symptoms. Patients treated with fluoxetine are in a stable pattern of use more likely than patients in the other antidepressants, this fact is related with better global therapeutic results.