RESUMEN
BACKGROUND: Self-management can be considered a way of dealing with oneself and relates to actions undertaken to create order, discipline, and control. The concept is closely linked to concepts of self-efficacy and self-regulation but can be distinguished from these. The Self-Management Self-Test (SMST) is a 5-item assessment scale designed to measure self-management competence in individuals with or without a psychiatric disorder (as screened using PHQ). The aim of this study was to validate the SMST in terms of convergent validity, the ability to differentiate, criterion validity, internal consistency, and test-retest reliability. METHODS: Eighty-seven adults hospitalized for treatment of major depression (clinical sample) and 595 individuals from the general population (population sample) filled out the SMST and 5 other stress-related psychometric instruments measuring similar constructs. All instruments were repeated 4 to 6 weeks later. Convergent validity, internal consistency, and test-retest reliability were tested based on data from the population sample. Convergent validity was determined by correlations with other stress-related psychometric instruments. Correlations in the range of r = -0.4 to -0.6 were expected. To test for criterion validity, the clinical sample was matched with a subsample from the population sample, consisting only of individuals without a psychiatric disorder as screened using PHQ (nonclinical subsample, n = 87). The ability to differentiate was based on receiver operating characteristic (ROC) curve analysis. RESULTS: Correlations between the SMST and the other stress-related tests were significant and in the expected direction and predominantly within the expected range (Pearson r = - 0.40 to -0.64). The correlation with the Multidimensional Fatigue Inventory-20, measuring fatigue, and with the dimensional scale for depression in the PHQ was higher than expected and referred to very similar items. Thus, convergent validity mainly lay within the expected range. Internal consistency was high (Cronbach α = 0.80), and test-retest reliability was fairly low (r = 0.71). The SMST showed a significant difference, t(157) = 7.97, P < .001, between the clinical sample (M = 9.36, SD = 3.39) and the nonclinical subsample (M = 12.94, SD = 2.47) with a large effect size (d = 1.3). The area under the ROC curve (AUC) was excellent (AUC = 0.81, SE = 0.034, P < .001), suggesting that the SMST can distinguish between the clinical and nonclinical samples. CONCLUSIONS: The SMST can be considered an effective self-rating test to assess self-management competence in individuals from the general population as well as in people with major depression. It may also be useful to detect treatment outcomes in people with major depression. The high internal consistency indicates that all 5 items are important for the test as a whole. The low test-retest reliability suggests sensitivity to change. The SMST is likely to differentiate particularly well at low levels of self-management competence, suggesting it may be a useful tool in studies investigating people with depression or other psychiatric disorders such as post-traumatic stress disorder. Furthermore, the SMST could be useful in assessing the effect of treatment interventions over time and evaluating patient-reported outcomes.
Asunto(s)
Automanejo , Adulto , Humanos , Psicometría , Reproducibilidad de los Resultados , AutoevaluaciónRESUMEN
BACKGROUND: Self-management can be considered a way of dealing with oneself and relates to actions undertaken to create order, discipline, and control. The concept is closely linked to concepts of self-efficacy and self-regulation but can be distinguished from these. The Self-Management Self-Test (SMST) is a 5-item assessment scale designed to measure self-management competence in individuals with or without a psychiatric disorder (as screened using PHQ). The aim of this study was to validate the SMST in terms of convergent validity, the ability to differentiate, criterion validity, internal consistency, and test-retest reliability. METHODS: Eighty-seven adults hospitalized for treatment of major depression (clinical sample) and 595 individuals from the general population (population sample) filled out the SMST and 5 other stress-related psychometric instruments measuring similar constructs. All instruments were repeated 4 to 6 weeks later. Convergent validity, internal consistency, and test-retest reliability were tested based on data from the population sample. Convergent validity was determined by correlations with other stress-related psychometric instruments. Correlations in the range of r = -0.4 to -0.6 were expected. To test for criterion validity, the clinical sample was matched with a subsample from the population sample, consisting only of individuals without a psychiatric disorder as screened using PHQ (nonclinical subsample, n = 87). The ability to differentiate was based on receiver operating characteristic (ROC) curve analysis. RESULTS: Correlations between the SMST and the other stress-related tests were significant and in the expected direction and predominantly within the expected range (Pearson r = -0.40 to -0.64). The correlation with the Multidimensional Fatigue Inventory-20, measuring fatigue, and with the dimensional scale for depression in the PHQ was higher than expected and referred to very similar items. Thus, convergent validity mainly lay within the expected range. Internal consistency was high (Cronbach α = 0.80), and test-retest reliability was fairly low (r = 0.71). The SMST showed a significant difference, t(157) = 7.97, P < .001, between the clinical sample (M = 9.36, SD = 3.39) and the nonclinical subsample (M = 12.94, SD = 2.47) with a large effect size (d = 1.3). The area under the ROC curve (AUC) was excellent (AUC = 0.81, SE = 0.034, P < .001), suggesting that the SMST can distinguish between the clinical and nonclinical samples. CONCLUSIONS: The SMST can be considered an effective self-rating test to assess self-management competence in individuals from the general population as well as in people with major depression. It may also be useful to detect treatment outcomes in people with major depression. The high internal consistency indicates that all 5 items are important for the test as a whole. The low test-retest reliability suggests sensitivity to change. The SMST is likely to differentiate particularly well at low levels of self-management competence, suggesting it may be a useful tool in studies investigating people with depression or other psychiatric disorders such as post-traumatic stress disorder. Furthermore, the SMST could be useful in assessing the effect of treatment interventions over time and evaluating patient-reported outcomes.
RESUMEN
OBJECTIVES: Music therapy is a well-established non-verbal treatment method in psychiatry and psychosomatic medicine. However, empirical data of its impact on emotion modulation processes and personality dimensions are still sparce. An interesting concept is the use of music for emotion modulation in everyday life. The purpose of this interim study was to assess the interplay of personality dimensions and emotion modulation strategies in patients treated with music therapy versus patients without music therapy. DESIGN: A cross-sectional design was used. SETTING: The study was conducted during the course of inpatient treatment in a general psychiatric hospital. Data from nâ¯=â¯137 patients was included in the analysis. MAIN OUTCOME MEASURES: According to the mediator model a regression analysis was performed using personality variables as potential predictors and emotion modulation variables as outcome criteria. RESULTS: In the music therapy group, insecurity predicted the use of music for both cognitive problem solving and positive stimulation in everyday life. In the non-music therapy group, cooperation and insouciance predicted the use of music for reduction of negative activation. CONCLUSIONS: Specific personality dimensions predict greater targeted emotion modulation strategies if music therapy is applied than without it. That is, music therapy helps patients acquire more conscious (i.e. cognitive-related strategies) emotion modulation techniques by means of including their individual personality, whereas patients without music therapy simply "vent" their negative emotions (i.e. non-cognitive strategies). Conversely, the data suggest that music therapy can contribute to modify personality dimensions through the development of these emotion modulation strategies. This could be a plausible explanation for beneficial long-term effects of music therapy.
Asunto(s)
Emociones , Trastornos Mentales/terapia , Musicoterapia , Música/psicología , Personalidad , Adulto , Cognición , Estudios Transversales , Femenino , Hospitales Psiquiátricos , Humanos , Masculino , Persona de Mediana Edad , Solución de Problemas , Psicoterapia de Grupo , Resultado del TratamientoRESUMEN
Although the efficacy and tolerability of ADHD medications have been investigated fairly extensively, there are very few data comparing the different types of medication (e.g. psychostimulants, non-stimulants) in terms of medication adherence. The primary research objective of the COMPLY observational study was to evaluate medication adherence (i.e. compliance) over 1 year in children and adolescents with ADHD in a routine clinical setting. COMPLY was a prospective 12-month, observational, open-label study that included children and adolescents, aged 6-17 years, with ADHD. Medication adherence (i.e. compliance) was measured using the Pediatric Compliance Self-Rating (PCSR) instrument and using items 1-4 of the Medication Adherence Rating Scale (MARS). A total of 504 patients were enrolled. At baseline, 252 patients (50.0 %) were prescribed non-stimulant (atomoxetine) medication and 247 patients (49.0 %) were prescribed psychostimulant medication. Both types of medication were prescribed concomitantly in five patients (1.0 %). After 12 months, 123 patients (48.8 %) were taking atomoxetine and 176 patients (71.3 %) were taking psychostimulants. Adherence (PCSR score ≥ 5) was present in both groups (atomoxetine: 67.5 %; psychostimulant: 74.2 %) throughout the observation period. MARS scores declined over time in both groups (atomoxetine: from 3.7 to 2.9; psychostimulant: from 3.6 to 3.1), indicating a deterioration in adherence. There was no statistically significant difference in terms of medication adherence between the two groups.
Asunto(s)
Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Trastorno por Déficit de Atención con Hiperactividad/psicología , Cumplimiento de la Medicación/psicología , Adolescente , Inhibidores de Captación Adrenérgica/efectos adversos , Inhibidores de Captación Adrenérgica/uso terapéutico , Clorhidrato de Atomoxetina/efectos adversos , Clorhidrato de Atomoxetina/uso terapéutico , Estimulantes del Sistema Nervioso Central/efectos adversos , Estimulantes del Sistema Nervioso Central/uso terapéutico , Niño , Femenino , Humanos , Masculino , Metilfenidato/efectos adversos , Metilfenidato/uso terapéutico , Estudios Prospectivos , Factores de TiempoRESUMEN
OBJECTIVE: To compare the reduction of ADHD symptoms under atomoxetine in patients with and without comorbid oppositional defiant disorder (ODD) or conduct disorder (CD) using a computer-based continuous performance test (cb-CPT) combined with an infrared motion tracking (MT) device. METHOD: Secondary analysis of a placebo-controlled study in ADHD patients (6-12 years old) treated with atomoxetine (target dose: 1.2 mg/kg per day). Cb-CPT/MT scores were analyzed using ANCOVA (last observation carried forward [LOCF]). RESULTS: The data (N = 125) suggested a more pronounced atomoxetine effect in the group with comorbid ODD/CD as measured by all cb-CPT/MT parameters except for "normalized variation of reaction time" (nVRT). CONCLUSION: The results showed that atomoxetine reduced ADHD severity as measured by cb-CPT and MT parameters regardless of whether comorbid ODD/CD was present. The treatment effect of atomoxetine on hyperactivity appears to be more pronounced in the subgroup of patients with comorbid ODD/CD than in the subgroup without this comorbidity.
Asunto(s)
Inhibidores de Captación Adrenérgica/uso terapéutico , Clorhidrato de Atomoxetina/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Déficit de la Atención y Trastornos de Conducta Disruptiva/epidemiología , Trastorno de la Conducta/epidemiología , Adolescente , Trastorno por Déficit de Atención con Hiperactividad/diagnóstico , Trastorno por Déficit de Atención con Hiperactividad/epidemiología , Déficit de la Atención y Trastornos de Conducta Disruptiva/diagnóstico , Comorbilidad , Método Doble Ciego , Femenino , Humanos , Masculino , Determinación de la Personalidad , Propilaminas/uso terapéutico , Calidad de Vida/psicología , Tiempo de Reacción/efectos de los fármacos , Resultado del TratamientoRESUMEN
The aim of this study was to explore the course of attention-deficit/hyperactivity disorder (ADHD) core symptoms, ADHD-related difficulties, and emotional expression during ADHD pharmacotherapy and associations between them. This prospective, observational study examines pediatric patients with ADHD who newly initiated stimulant, atomoxetine or a combination of both treatments. Data were collected at baseline; weeks 1, 2, and 4; and months 3, 6, 9, and 12. Physicians rated ADHD core symptoms using the ADHD Rating Scale (ADHD-RS); patients, parents, and physicians rated ADHD-related difficulties using the Global Impression of Perceived Difficulties (GIPD) Scale; and patients and parents rated emotional expression using the Expression of Emotion Scale for Children (EESC). Results were analyzed using mixed model repeated measures. Associations are presented by Spearman's correlations. Overall, 504 patients, mean age 9.6 years, 72.6% males, were analyzed. Fifty percent of patients started atomoxetine, 49.0% stimulant and 1% a combination of both. ADHD-RS, GIPD, and EESC scores decreased significantly in both monotherapy groups. Correlations between ADHD-RS and parent- or physician-rated GIPD scores were at-best moderate and increased over time but remained low to moderate for patient-rated GIPD [patient, r=0.43 (95% CI 0.34, 0.51); parent, r=0.58 (0.50, 0.64); physician, r=0.55 (0.48, 0.62)]. Correlations between ADHD-RS and patient- or parent-rated EESC scores were low at baseline (r<0.2) and increased over time mostly for parent ratings [patient, r=0.35 (0.26, 0.44); parent, r=0.41 (0.32, 0.50)]. These data support the effectiveness of ADHD pharmacotherapy. The at-best moderate correlations between ADHD core symptoms and ADHD-related difficulties or emotional expression assessed by different raters indicate potentially important patient outcomes beyond core symptoms.
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Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Trastorno por Déficit de Atención con Hiperactividad/psicología , Estimulantes del Sistema Nervioso Central/uso terapéutico , Propilaminas/uso terapéutico , Adolescente , Inhibidores de Captación Adrenérgica/efectos adversos , Inhibidores de Captación Adrenérgica/uso terapéutico , Clorhidrato de Atomoxetina , Trastorno por Déficit de Atención con Hiperactividad/diagnóstico , Estimulantes del Sistema Nervioso Central/efectos adversos , Niño , Quimioterapia Combinada , Emociones , Femenino , Humanos , Masculino , Propilaminas/efectos adversos , Estudios Prospectivos , Calidad de Vida/psicología , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVE: To compare the reduction of ADHD symptoms under atomoxetine (ATX) in patients with and without pretreatment with a stimulant medication using a computer-based Continuous Performance Test (cb-CPT) combined with an infrared motion tracking (MT) device. METHOD: Double-blind, placebo-controlled study in ADHD patients (6-12 years) treated with ATX (target dose = 1.2 mg/kg per day). The cb-CPT/MT scores were analyzed using ANCOVA (last observation carried forward). RESULTS: Patient data (n = 125) suggested a differential ATX treatment effect between pretreated and stimulant-naïve patients in terms of three cb-CPT/MT parameters. CONCLUSION: This secondary analysis provided evidence that ATX reduced ADHD symptom severity measured by cb-CPT/MT parameters regardless of stimulant pretreatment. A few differential effects were seen based on the cb-CPT/MT. However, no clear pattern could be identified and, overall, the observed differences have no larger clinical relevance. The ATX effect in this study seemed to be largely independent of any previous exposure to stimulants.
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Inhibidores de Captación Adrenérgica/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Propilaminas/uso terapéutico , Clorhidrato de Atomoxetina , Trastorno por Déficit de Atención con Hiperactividad/diagnóstico , Trastorno por Déficit de Atención con Hiperactividad/psicología , Estimulantes del Sistema Nervioso Central/uso terapéutico , Niño , Diagnóstico por Computador , Método Doble Ciego , Femenino , Humanos , Masculino , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Schizophrenia is associated with impaired sleep continuity. The second generation antipsychotics clozapine and olanzapine have been reported to improve sleep continuity but also to rarely induce restless legs syndrome (RLS). The aims of this randomized double-blind study were to compare the effects of clozapine and olanzapine on sleep and the occurrence of RLS. Therefore, polysomnographies were recorded and RLS symptoms were assessed in 30 patients with schizophrenia before and after 2, 4 and 6 weeks of treatment with either clozapine or olanzapine. Treatment with both antipsychotics increased total sleep time, sleep period time and sleep efficiency and decreased sleep onset latency. These changes were similar in both groups, occurred during the first 2 treatment weeks and were sustained. For example, sleep efficiency increased from 83% (olanzapine) and 82% (clozapine) at baseline to 95% at week 2 and 97% at week 6 in both treatment groups. Sleep architecture was differently affected: clozapine caused a significantly stronger increase of stage 2 sleep (44%) than olanzapine (11%) but olanzapine a significantly stronger increase of REM-sleep. Olanzapine caused an 80% increase of slow wave sleep whereas clozapine caused a 6% decrease. No patient reported any of 4 RLS defining symptoms at baseline. During treatment, 1 patient of each group reported at one visit all 4 symptoms, i.e. met the diagnosis of an RLS. In conclusion, sleep continuity similarly improved and sleep architecture changed more physiologically with olanzapine. Neither of the antipsychotics induced RLS symptoms that were clinically relevant.
Asunto(s)
Antipsicóticos/uso terapéutico , Benzodiazepinas/uso terapéutico , Clozapina/uso terapéutico , Polisomnografía , Esquizofrenia/complicaciones , Trastornos del Sueño-Vigilia , Adolescente , Adulto , Anciano , Análisis de Varianza , Bases de Datos Factuales/estadística & datos numéricos , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Olanzapina , Esquizofrenia/tratamiento farmacológico , Trastornos del Sueño-Vigilia/diagnóstico , Trastornos del Sueño-Vigilia/tratamiento farmacológico , Trastornos del Sueño-Vigilia/etiología , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
The primary objective of this study was to evaluate the efficacy of atomoxetine (ATX) on attention-deficit/hyperactivity disorder (ADHD)-related symptoms assessed as standard variables of a computer-based continuous performance test (cb-CPT) combined with a motion-tracking (MT) device. This was a 2-arm, 8-week, randomized, double-blind, placebo-controlled study in patients with ADHD (6-12 years). Therapy with ATX started with 0.5 mg/kg per day for 1 week, followed by 7 weeks on the target dosage of 1.2 mg/kg per day. Primary outcomes were cb-CPT/MT standard scores after 8 weeks using mixed models for repeated measurements. In addition, investigator-rated ADHD Rating Scale (ADHD-RS), Weekly Ratings of Evening and Morning Behavior (WREMB), and Clinical Global Impression - Severity-ADHD (CGI-S-ADHD) scores were assessed. Of 128 patients randomized, 125 were evaluated (ATX/placebo: 63/62). Baseline characteristics were comparable in both groups (overall, 80.2% boys; mean [SD] age, 9.0 [1.79] years; comorbid Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis, 40.0% oppositional defiant disorder/conduct disorder; prior stimulant treatment, 24.8%; ADHD-RS total score, 36.99 [11.56]). At week 8, all cb-CPT/MT q-scores were significantly reduced versus placebo (all P < 0.001) with effect sizes (ESs) of reaction time (RT) variation (ES = 0.71), mean RT (ES = 0.41), number of microevents (ES = 1.00), commission error rate (ES = 0.50), distance of movement (ES = 0.90), area of movement (ES = 1.08), omission error rate (ES = 0.70), time active (ES = 0.69), motion simplicity (ES = 0.38), and normalized variance of RT (ES = 0.50). Secondary end points also improved significantly in favor of ATX: ADHD-RS (total score ES = 1.30, P < 0.001; hyperactivity/impulsivity subscore ES = 1.37, P < 0.001; inattention subscore ES = 1.07, P < 0.001), WREMB (total score ES = 1.00, P < 0.001; morning subscore ES = 0.59, P = 0.002; evening subscore ES = 1.02, P < 0.001), CGI-S-ADHD (ES = 1.11, P < 0.001). The results of this study show that ATX for 8 weeks significantly reduced ADHD-related symptoms as measured by the cb-CPT/MT.
Asunto(s)
Inhibidores de Captación Adrenérgica/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Propilaminas/uso terapéutico , Inhibidores de Captación Adrenérgica/administración & dosificación , Clorhidrato de Atomoxetina , Trastorno por Déficit de Atención con Hiperactividad/fisiopatología , Niño , Diagnóstico por Computador , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Función Ejecutiva/efectos de los fármacos , Femenino , Humanos , Masculino , Propilaminas/administración & dosificación , Escalas de Valoración Psiquiátrica , Tiempo de Reacción/efectos de los fármacos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Sleep propensity at daytime has not been investigated in untreated patients with schizophrenia. Furthermore, while the antipsychotics clozapine and olanzapine are considered to frequently cause 'sleepiness' or 'sedation', this has not been objectified yet. Therefore, 30 patients with schizophrenia were included in this randomized, double-blind study. Sleep propensity was assessed before and after 2, 4 and 6 weeks of treatment with either clozapine or olanzapine using a Multiple Sleep Latency Test (MSLT); in the MSLT, sleep latencies of 5 nap opportunities of 20 min during daytime are averaged. In addition, the number of sleep onsets was recorded. Mean sleep latency in untreated schizophrenic patients was 16.2 ± 0.8 min at baseline. Both antipsychotics induced an increase of sleep propensity as indicated by a shortened sleep latency and more sleep onsets during the treatment period as compared to baseline. These effects were strongest in the morning. Four patients receiving clozapine and 3 patients receiving olanzapine reported subjective sleepiness, in all but one commencing in the first treatment week and persisting until study end. While the mean sleep latency during treatment was significantly shorter in these patients (12.3 ± 0.8 min) than in those without subjective sleepiness (14.9 ± 0.7 min), a short sleep latency was not necessarily associated with subjective sleepiness. In conclusion, mean sleep latency was >36% longer (i.e. sleep propensity was lower) in untreated patients with schizophrenia than in healthy subjects previously consistently reported. Furthermore, clozapine and olanzapine increased sleep propensity in schizophrenic patients. A minority of patients reported subjective sleepiness.
Asunto(s)
Antipsicóticos/uso terapéutico , Benzodiazepinas/uso terapéutico , Clozapina/uso terapéutico , Trastornos de Somnolencia Excesiva/tratamiento farmacológico , Esquizofrenia/tratamiento farmacológico , Adolescente , Adulto , Anciano , Análisis de Varianza , Trastornos de Somnolencia Excesiva/etiología , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Olanzapina , Polisomnografía , Escalas de Valoración Psiquiátrica , Tiempo de Reacción/efectos de los fármacos , Esquizofrenia/complicaciones , Fases del Sueño/efectos de los fármacos , Estadística como Asunto , Factores de Tiempo , Adulto JovenRESUMEN
Attention-deficit/hyperactivity disorder (ADHD) is associated with considerable impairment in health-related quality of life (HR-QoL). Atomoxetine has been found to improve HR-QoL in both children and adolescents. However, there is scarcity of data on gender differences in treatment responses to ADHD medications. This pooled analysis of five atomoxetine trials aimed to evaluate treatment differences with respect to HR-QoL and ADHD symptoms across genders. Data from 5 clinical atomoxetine trials (4 from Europe and 1 from Canada) with similar inclusion and exclusion criteria and similar durations (8- to 12-week follow-up) were included in the pooled analysis. All studies included the Child Health and Illness Profile-Child Edition (CHIP-CE) Parent Report Form. In addition, correlations between HR-QoL and ADHD core symptoms were compared between girls and boys. Data from 136 girls and 658 boys (mean age: 9.6 and 9.7 years, respectively) were pooled. Boys and girls were similarly impaired at baseline with minor differences in some of the subdomains. Treatment effect of atomoxetine was significant in both groups for the Risk Avoidance domain and its subdomains. No gender effect with both clinical and statistical significance was found for treatment outcome. Correlations between ADHD Rating Scale and CHIP-CE scores were similar in both genders and were generally low at baseline and moderate at endpoint and for the change from baseline to endpoint. Atomoxetine was effective in improving some aspects of HR-QoL in both genders without any significant differences across genders. Correlations between core symptoms of ADHD and HR-QoL were low to moderate in both boys and girls.
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Trastorno por Déficit de Atención con Hiperactividad/psicología , Ensayos Clínicos como Asunto/estadística & datos numéricos , Calidad de Vida/psicología , Caracteres Sexuales , Clorhidrato de Atomoxetina , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Canadá , Niño , Ensayos Clínicos como Asunto/métodos , Europa (Continente) , Femenino , Estado de Salud , Humanos , Masculino , Propilaminas/uso terapéutico , Índice de Severidad de la EnfermedadRESUMEN
The effect of atomoxetine (ATX) on executive function has been assessed by means of questionnaires only. The aim of this study was therefore to evaluate the efficacy of ATX using standard variables of a computer-based continuous performance test (cb-CPT) combined with an infra-red motion-tracking device at different times of the day. One hundred twenty-eight girls and boys aged 6 to 12 years with a diagnosis of ADHD according to DSM-IV-TR criteria were randomized in the study. The primary efficacy measures were the q-scores of the cb-CPT combined with an infra-red motion-tracking device. The test comprises 13 neuropsychological variables that can be taken to reflect hyperactivity, inattention, or impulsivity. One hundred five patients completed the study (ATX group: n=54; placebo group: n=51). ATX (target dose 1.2 mg/kg/day) over 8 weeks was significantly superior to placebo in reducing hyperactivity, inattention, and impulsivity as measured by q-scores of 10 primary variables of the cb-CPT. Both groups of patients showed a circadian pattern of neuropsychological outcomes across the day as reflected by the cb-CPT combined with an infra-red motion-tracking device. In summary, this study demonstrated a positive effect of ATX on some aspects of executive function, inhibitory control, and hyperactivity compared with placebo.
Asunto(s)
Inhibidores de Captación Adrenérgica/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Propilaminas/uso terapéutico , Clorhidrato de Atomoxetina , Trastorno por Déficit de Atención con Hiperactividad/psicología , Niño , Diagnóstico por Computador , Método Doble Ciego , Femenino , Humanos , Masculino , PlacebosRESUMEN
Our aim was to evaluate the psychometric properties of the generic quality of life (QoL) scale Child Health and Illness Profile-Child Edition (CHIP-CE) by means of a combined analysis of atomoxetine clinical trials in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Individual patient-level data from five clinical trials were included in the combined analysis. Psychometric properties of the CHIP-CE were explored in terms of internal consistency and structure. Patients (n=794) aged between 6 and 15 years (mean 9.7) with mean baseline ADHD Rating Scale of 41.8±8.04 were included. On average, 0.7 (SD 2.23) items were missing for the whole CHIP-CE. The internal consistency of the CHIP-CE assessed by Cronbach's alpha was good for all sub-domains at baseline and at endpoint. Considerable ceiling effects were only observed for the "restricted activity" sub-domain. No considerable floor effects were seen. The factor analysis supported the 12-factor solution for the sub-domains, but not the 5-factor solution for the domains. Our analyses were based on a large sample of non-US patients which allowed the measurement of clear changes in QoL over time. The results support that the CHIP-CE scale is psychometrically robust over time in terms of internal consistency and structure.
Asunto(s)
Inhibidores de Captación Adrenérgica/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/psicología , Ensayos Clínicos como Asunto/estadística & datos numéricos , Propilaminas/uso terapéutico , Escalas de Valoración Psiquiátrica/estadística & datos numéricos , Psicometría/estadística & datos numéricos , Calidad de Vida/psicología , Adolescente , Clorhidrato de Atomoxetina , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Niño , Análisis Factorial , Femenino , Humanos , MasculinoRESUMEN
OBJECTIVES: The primary objective of this study was to evaluate the efficacy of atomoxetine (ATX, target dose 1.2 mg/kg daily) on symptoms of oppositional defiant disorder (ODD) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). A secondary objective was to compare fast versus slow up-titration of ATX. METHODS: This was a 3-arm, 9-week, randomized, placebo-controlled, double-blind study in ADHD patients (6-17 years) with comorbid ODD (Diagnostic and Statistical Manual of Mental Disorders, 4th edition [DSM-IV] criteria A-C) or conduct disorder (CD). ATX-treatment arms were as follows-ATX-fast: 7 days 0.5 mg/kg, then 1.2 mg/kg; ATX-slow: 7 days each at 0.5 and 0.8 mg/kg, then 1.2 mg/kg. Primary outcome was the Swanson, Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ODD-score after 9 weeks (Mixed Effects Model for Repeated Measures, ATX-up-titration groups pooled). RESULTS: In total, 181 patients were randomized, and 180 evaluated (ATX-fast/ATX-slow/placebo: 60/61/59). Baseline characteristics were comparable (84.4% boys; mean age 11.0 years; DSM-IV: 100% ADHD, 75.6% with combined type, 74.4% ODD, 24.4% CD; SNAP-IV ODD-scores, mean ± standard deviation 15.5 ± 4.35). At week 9, SNAP-IV ODD scores were significantly lower versus placebo in both ATX-groups (least square mean [95% confidence interval]: ATX-fast 8.6 [7.2;9.9]; ATX-slow 9.0 [7.7;10.3]; placebo 12.0 [10.6;13.5]; least square mean, ATX-pooled minus placebo: -3.2 [-5.0, -1.5], effect size: -0.69, p < 0.001). SNAP-IV ADHD-scores, CD symptoms (investigator-rated Attention-Deficit and Disruptive Behavior Disorders Instrument, disruptive behavior), Clinical Global Impressions-Severity, and individual treatment behaviors showed corresponding results. Post-hoc analyses indicated interrelationships between the medication effects on ADHD, ODD, and CD symptom scores. For ATX-slow, time to early dropout was significantly longer versus placebo (Hazard Ratio [95% confidence interval]: 3.57 [1.42;8.94]; p = 0.007). Clinically relevant adverse effects (fatigue, sleep disorders, nausea, and gastrointestinal complaints; weeks 1-3) were reported in 60.0% of ATX-fast, 44.3% of ATX-slow, and 18.6% of placebo group patients. CONCLUSIONS: ATX for 9 weeks significantly reduced symptoms of ODD/CD and ADHD; slower ATX-up-titration may be better tolerated.
Asunto(s)
Inhibidores de Captación Adrenérgica/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Déficit de la Atención y Trastornos de Conducta Disruptiva/tratamiento farmacológico , Propilaminas/uso terapéutico , Adolescente , Inhibidores de Captación Adrenérgica/efectos adversos , Clorhidrato de Atomoxetina , Atención/efectos de los fármacos , Atención/fisiología , Trastorno por Déficit de Atención con Hiperactividad/complicaciones , Déficit de la Atención y Trastornos de Conducta Disruptiva/complicaciones , Niño , Comorbilidad , Trastorno de la Conducta/epidemiología , Progresión de la Enfermedad , Método Doble Ciego , Femenino , Alemania , Humanos , Masculino , Placebos , Propilaminas/efectos adversos , Resultado del TratamientoRESUMEN
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 ProspectivosRESUMEN
PURPOSE: To evaluate the effect of atomoxetine on quality of life (QoL) and family burden in children and adolescents with attention deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant (ODD) or conduct disorder (CD). METHODS: This secondary analysis was based on a randomized, double-blind, 9-week study of atomoxetine (target dose 1.2 mg/kg body weight) versus placebo. The study included 180 patients (atomoxetine 121, placebo 59), aged 6-17 years. QoL was measured using the KINDL-R questionnaire. The total score encompasses six dimensions (or subscales) measuring QoL in terms of "physical well-being", "emotional well-being", "self-esteem", "friends", "family", and "school". Family burden of illness was measured using the FaBel questionnaire. RESULTS: With atomoxetine, the KINDL-R total score improved significantly (P = 0.021) more than with placebo. This improvement also applied to the subscales except for "physical well-being" (opposite effect) and "school" (no effect). No significant treatment group differences were seen on the FaBel questionnaire. No differences were found between the fast and slow titration groups in terms of ADHD, ODD, and disruptive behavior severity. Furthermore, no such differences were observed for QoL and family burden. CONCLUSIONS: This study suggests positive effects of atomoxetine on quality of life, as measured by the KINDL-R scores on emotional well-being, self-esteem, friends and family, in children and adolescents with ADHD and comorbid ODD/CD. No significant treatment effects were seen on family burden, as measured by FaBel total score.
Asunto(s)
Inhibidores de Captación Adrenérgica/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Trastorno de la Conducta/tratamiento farmacológico , Relaciones Familiares , Propilaminas/uso terapéutico , Adaptación Psicológica , Adolescente , Conducta del Adolescente , Inhibidores de Captación Adrenérgica/farmacología , Análisis de Varianza , Clorhidrato de Atomoxetina , Trastorno por Déficit de Atención con Hiperactividad/epidemiología , Trastorno por Déficit de Atención con Hiperactividad/psicología , Niño , Protección a la Infancia , Trastorno de la Conducta/epidemiología , Trastorno de la Conducta/psicología , Intervalos de Confianza , Método Doble Ciego , Femenino , Humanos , Masculino , Propilaminas/farmacología , Psicometría , Autoimagen , Estrés Psicológico , Estudiantes de Medicina , Encuestas y CuestionariosRESUMEN
OBJECTIVES: To explore the influence of age on treatment responses to atomoxetine and to assess the relationship between core symptoms of attention deficit/hyperactivity disorder (ADHD) and health-related quality of life (HR-QoL) outcomes. DATA SOURCES: Data from five similar clinical trials of atomoxetine in the treatment of children and adolescents with ADHD were included in this meta-analysis. STUDY SELECTION: Atomoxetine studies that used the ADHD Rating Scale (ADHD-RS) and the Child Health and Illness Profile Child Edition (CHIP-CE) as outcome measures were selected. INTERVENTIONS: Treatment with atomoxetine. MAIN OUTCOME MEASURES: Treatment group differences (atomoxetine vs placebo) in terms of total score, domains, and subdomains of the CHIP-CE were compared across age groups, and correlations between ADHD-RS scores and CHIP-CE scores were calculated by age. RESULTS: Data of 794 subjects (611 children, 183 adolescents) were pooled. At baseline, adolescents showed significantly (p < 0.05) greater impairment compared with children in the Family Involvement, Satisfaction with Self, and Academic Performance subdomains of the CHIP-CE. Treatment effect of atomoxetine was significant in both age groups for the Risk Avoidance domain and its subdomains. There was a significant age-treatment interaction with greater efficacy seen in adolescents in both the Risk Avoidance domain and the Threats to Achievement subdomain. Correlations between ADHD-RS and CHIP-CE scores were generally low at baseline and moderate in change from baseline and were overall similar in adolescents and children. CONCLUSIONS: Atomoxetine was effective in improving some aspects of HR-QoL in both age groups. Correlations between core symptoms of ADHD and HR-QoL were low to moderate.
RESUMEN
The objective of this pooled analysis was to correlate parameters related to quality of life with attention-deficit/hyperactivity disorder (ADHD) core symptoms analyzing data of 5 atomoxetine clinical trials in children and adolescents with ADHD. Data from 5 clinical trials (4 from Europe and 1 from Canada) with similar inclusion/exclusion criteria and similar duration (8-12 weeks' follow-up) were included. All studies used the Child Health and Illness Profile, Child Edition (CHIP-CE), parent rating form at baseline and end point. Correlation coefficients and effect sizes to ADHD-Rating Scale (ADHD-RS) scores were calculated. A total of 794 patients aged 6 to 15 years (mean, 9.7 years), with mean (SD) baseline Clinical Global Impression of Severity of 4.8 (0.89) and ADHD-RS of 41.8 (8.04), were included. Baseline total CHIP-CE mean t score (standard, 50 [10]) was 28.9 (11.76), and the strongest impairments were seen in risk avoidance (30.2 [14.62]) and achievement (30.5 [10.4]) domains. At baseline, CHIP-CE versus ADHD-RS correlation was low (total, -0.345) except for the risk avoidance domain (total, -0.517). For changes from baseline to end point, a low correlation between the scales was found (total, -0.364; placebo-controlled studies only, n = 372). Quality of life impairment in ADHD was found in CHIP-CE total score and several domains. Correlations between CHIP-CE and ADHD-RS at baseline, end point, and for change from baseline to end point were low to moderate. These findings suggest that measuring quality of life adds clinically relevant insight beyond core symptom evaluation in children and adolescents with ADHD.
Asunto(s)
Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Trastorno por Déficit de Atención con Hiperactividad/psicología , Propilaminas/uso terapéutico , Calidad de Vida/psicología , Ensayos Clínicos Controlados Aleatorios como Asunto , Adolescente , Clorhidrato de Atomoxetina , Trastorno por Déficit de Atención con Hiperactividad/epidemiología , Canadá/epidemiología , Niño , Ensayos Clínicos como Asunto/métodos , Europa (Continente)/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
This review provides an overview as to how the social and emotional impairments involved in Attention-Deficit/Hyperactivity Disorder affect the quality of life of patients and their families. A model of three categories into which the emotional difficulties fall, and how they impair quality of life, is also presented.