Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate.

Attention-deficit/hyperactivity disorder (ADHD) is associated with functional impairments in multiple domains of patients' lives. A secondary objective of this randomized, active-controlled, head-to-head, double-blind, dose-optimized clinical trial was to compare the effects of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) on functional impairment in children and adolescents with ADHD. Patients aged 6-17 years with an ADHD Rating Scale IV total score ≥ 28 and an inadequate response to methylphenidate treatment (judged by investigators) were randomized (1:1) to once-daily LDX or ATX for 9 weeks. Parents/guardians completed the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) at baseline and at week 9 or early termination. p values were nominal and not corrected for multiple comparisons. Of 267 randomized patients, 200 completed the study (LDX 99, ATX 101). At baseline, mean WFIRS-P total score in the LDX group was 0.95 [standard deviation (SD) 0.474; 95% confidence interval (CI) 0.87, 1.03] and in the ATX group was 0.91 (0.513; 0.82, 1.00). Scores in all WFIRS-P domains improved from baseline to endpoint in both groups, with least-squares mean changes in total score of -0.35 (95% CI -0.42, -0.29) for LDX and -0.27 (-0.33, -0.20) for ATX. The difference between LDX and ATX was statistically significant (p < 0.05) for the Learning and School (effect size of LDX vs ATX, 0.43) and Social Activities (0.34) domains and for total score (0.27). Both treatments reduced functional impairment in children and adolescents with ADHD; LDX was statistically significantly more effective than ATX in two of six domains and in total score.

Long-term quality-of-life and functioning comparison of atomoxetine versus other standard treatment in pediatric attention-deficit/hyperactivity disorder.

Psychopharmacological agents were shown to be important for improving the quality of life (QoL) of patients with attention-deficit/hyperactivity disorder (ADHD). A short-term, 10-week study found atomoxetine (ATX) to be effective in improving QoL of ADHD patients. We compared, for the first time, long-term treatment outcomes of ATX and other early standard therapy (OEST, any pharmacological ADHD treatment except ATX) in QoL and functional impairment in pharmacologically naive children/ adolescents in a randomized, controlled, open-label study at 6 and 12 months. Patients received ATX (0.5-1.8 mg/kg per day) or OEST (mainly methylphenidate). Quality of life and functioning were assessed by the Child Health and Illness Profile-Child Edition, Parent Rating Form and the Weiss Functional Impairment Rating Scale-Parent Report. Three hundred ninety-eight patients (79.4% male; mean age, 9.3 years) received study treatment. The Child Health and Illness Profile-Child Edition, Parent Rating Form achievement domain t scores significantly improved from baseline to 6 months from means of 28.0 to 37.1 for ATX and from 28.3 to 40.7 for OEST. Mean t scores at 12 months were 40.0 for ATX and 41.0 for OEST. The Weiss Functional Impairment Rating Scale-Parent Report total score improved from baseline to 6 months in both groups (ATX: mean 1.02 to 0.63; OEST: 0.96 to 0.59). Both treatments were safe with no statistically significant difference in the overall rate of adverse events. Overall, the improvements in QoL and functional impairment observed over time for ATX and OEST were meaningful and stable over the study period of 12 months. Between-group differences were small but sometimes statistically significant, providing the first-time long-term comparative symptomatic and QoL analysis between ATX and OEST.

Distinctions between sluggish cognitive tempo, ADHD-IN, and depression symptom dimensions in Spanish first-grade children.

The objective of this study was to evaluate the validity of a new parent rating scale of Sluggish Cognitive Tempo (SCT). SCT was defined with 10 symptom domains--daydreams; attention fluctuates; absentminded; loses train of thought; easily confused; seems drowsy; thinking is slow; slow-moving; low initiative; and easily bored, needs stimulation--with each domain represented by multiple examples. Mothers' and fathers' ratings of SCT, ADHD-IN, ADHD-HI, oppositional defiant disorder (ODD), and depression symptoms along with ratings of academic and social impairment were obtained for a sample of 802 Spanish first-grade children (54% boys). SCT Symptom Domains 4 to 8 showed substantial loadings on the SCT factor (i.e., convergent validity) and substantially higher loadings on the SCT factor than the ADHD-IN factor (i.e., discriminant validity). This 5-domain measure of SCT showed good interrater and test-retest reliability for a 6-week interval. Higher scores on the 5-domain measure of SCT predicted higher levels of academic and social impairment even after controlling for ADHD-IN and depression. In contrast, higher levels of SCT were not uniquely related (or uniquely negatively related) to ADHD-HI and ODD, whereas ADHD-IN and depression were uniquely positively related to ADHD-HI and ODD. The new measure of SCT more clearly establishes that SCT, ADHD-IN, and depression represent independent symptom dimensions, thus providing a measurement tool to help determine if SCT and ADHD-IN dimensions have unique biological correlates and if SCT and ADHD meet the criteria for different disorders.

Evaluating Internet information on attention-deficit/hyperactivity disorder (ADHD) treatment: parent and expert perspectives.

BACKGROUND: The Internet is increasingly used as a source of health-related information. The objective of this study was to assess the quality of web-based information on treatments for attention-deficit/hyperactivity disorder (ADHD). METHODS: Sixteen expert health professionals in ADHD and 35 parents of paediatric patients with a recent diagnosis of ADHD assessed the information contained in the 10 highest ranked websites in Spanish, using the Spanish version of the DISCERN tool - a validated questionnaire designed to assess the quality and reliability of web-based information on treatment choices (rating scores from 15 to 75). RESULTS: DISCERN scores given by parents and experts were low (total mean scores [standard deviation]: 35.9 [13.1] and 43.4 [13.7], respectively) and inter-rater agreement was poor/moderate (weighted kappa for the global assessment between -0.69 and +0.93, average = 0.29). There was a significant change on the ADHD-knowledge and motivation for treatment (ADHD-KMT) basic knowledge sub-scale score after the assessment of the different websites by parents (total mean scores [standard deviation]: 49.09 [9.46] and 63.21 [9.45]). CONCLUSIONS: Despite a poor/moderate inter-rater agreement between parent and expert opinions, all agreed that the quality of the web-based information on treatment choices for ADHD is generally poor.

Perinatal psychological interventions to promote breastfeeding: a narrative review.

BACKGROUND: Emotional distress in mothers inhibits the let-down reflex, thus affecting breastfeeding self-efficacy. A breastfeeding mother may have to cope with both physical discomfort and psychological distress. However, literature on initiatives to improve breastfeeding rates has focused mainly on providing community-based peer support, or social policies. The aim of this review is to assess evidence on the effectiveness of a broad range of psychological interventions to facilitate breastfeeding for mothers facing difficulties around the time of delivery. METHODS: The review of the literature is derived from a search on Cochrane Library, PubMed, EBSCOhost, and PsycINFO for papers published since 1980. The approach was to explore quantitative and qualitative parameters. Quantitative parameters included breastfeeding initiation, duration, and composition. Qualitative parameters recorded the evaluation of maternal perceptions on breastfeeding success. The high heterogeneity of the studies led to a narrative review; 20 selected papers that report on breastfeeding outcomes and psychological programs met the inclusion criteria. RESULTS: The evidence on breastfeeding support through psychotherapy is heterogeneous and scant. Out of the included studies, 11 were randomized controlled trials, two were non-randomised trials, and two used a quasi-experimental design. None of the studies reported an increase in adverse breastfeeding outcomes. Three studies failed to report an association between psychological procedures and improved breastfeeding outcomes. A literature review showed that 17 (85%) analyses support stress-releasing techniques to facilitate breastfeeding. CONCLUSIONS: This review suggests that relaxation interventions carefully tailored to address perinatal emotional distress may lead to important health benefits, including improvement in breastfeeding outcomes. There is also some indication that psychotherapy support while breastfeeding may have more impact than routine counselling. Conversely, this review did not find an association between self-hypnosis and breastfeeding outcomes. Data from this study can be used in designing prevention programs and future research with appropriate theoretical underpinning.

Understanding trait and sources effects in attention deficit hyperactivity disorder and oppositional defiant disorder rating scales: mothers', fathers', and teachers' ratings of children from the Balearic Islands.

Confirmatory factor analysis was used to model a multitrait (attention deficit hyperactivity disorder [ADHD]-inattention, ADHD-hyperactivity/impulsivity, oppositional defiant disorder [ODD]) by multisource (mothers, fathers, and teachers) matrix to determine the convergent and discriminant validity of ratings by mothers, fathers, and teachers. Participants were 1,749 elementary school children from the island of Majorca in the Balearic Islands. The results showed good convergent validity for the measures for mothers' and fathers' ratings with moderate support for the measures discriminant validity for mothers' and fathers' ratings. There was no convergent and discriminant validity, however, between mothers' and teachers' as well as fathers' and teachers' ratings for the ADHD-IN, ADHD-HI, and ODD measures. The results provide additional evidence that the construct validity of parent and teacher ADHD/ODD rating scales is mostly parent (home) and teacher (school) specific.

[Benefits of mindfulness in pregnant women]. / Beneficios del mindfulness en mujeres embarazadas.

This article is intended to review the effect of mindfulness-based interventions on perinatal mental health. A search of the literature published until September 2019 in the Web of Science (WOS) database was carried out. Taking into account the inclusion and exclusion criteria and after reading the title and abstracts of the articles found, 26 of them have been selected. Finally we only analyzed randomized controlled trials (RCTs) that show data on anxiety, depression, perceived stress and mindfulness before and after intervention and with follow-up data. The results found show that mindfulness-based interventions (IBMs) are more effective than the usual healthcare (TAU) that pregnant women receive for the reduction of depressive, anxious and perceived stress symptoms as well as increasing their postintervention mindfulness levels. For future research, a postpartum follow-up would be considered interesting taking into account variables such as the quality of the mother-baby attachment, adherence to breastfeeding and the evolutionary development of the newborn.

Este trabajo tiene el propósito de revisar el efecto de las intervenciones basadas en mindfulness sobre la salud mental perinatal. Se efectuó una búsqueda de la literatura publicada hasta septiembre 2019 en la base de datos Web of Science (WOS). Teniendo en cuenta los criterios de inclusión y exclusión y después de leer el título y abstracts de los artículos encontrados, se han seleccionado 26 de ellos, de los que se han escogido solo ocho por tratarse de ensayos controlados y aleatorizados (RCTs) que estudian datos de ansiedad, depresión, estrés percibido y mindfulness pre y post-intervención y con datos de seguimiento. Los resultados encontrados muestran que las intervenciones basadas en mindfulness (IBMs) son más eficaces que la asistencia sanitaria habitual (TAU) para la mujer embarazada a la hora de reducir la sintomatología depresiva, ansiosa y estrés percibido e incrementar sus niveles de mindfulness post-intervención. Para futuras investigaciones se consideraría interesante realizar el seguimiento de estas variables en el posparto e incluir otras como la calidad del vínculo madre-bebé, la adherencia a la lactancia materna y el desarrollo evolutivo del recién nacido.

[Is attention deficit hyperactivity disorder associated with other prevalent pathologies of early childhood?]. / ¿Se asocia el trastorno por déficit de atención/hiperactividad con otras patologías prevalentes de la infancia?

AIM: To determine whether attention deficit hyperactivity disorder (ADHD) is associated with other prevalent medical pathologies of the paediatric age. DEVELOPMENT: Several paediatric pathologies were selected with the aim of reviewing their association with ADHD: in paediatric pulmonology, asthma and other allergic processes; in paediatric neurology, headache and febrile seizures; in paediatric gastroenterology, diarrhoea, constipation, abdominal pain, gastroesophageal reflux and infection by Helicobacter pylori; in paediatric nephrology, enuresis; in paediatric cardiology, bruits and congenital heart disease; in paediatric endocrinology, thyroid disorders and obesity; and in paediatric ophthalmology, ametropia and strabismus. CONCLUSIONS: Several studies were found that related ADHD with allergic processes, overweight/obesity, peripheral resistance to thyroid hormone, enuresis, febrile seizures, headache, congenital heart disease, ophthalmic disorders and tooth decay, with some controversial issues and details still to be defined. It can be concluded that further interdisciplinary studies are needed to clarify the associations and underlying mechanisms involved, so as to be able to gain a deeper understanding of the complex entity of ADHD and to suggest preventive, diagnostic and therapeutic interventions with regard to its comorbidities.

TITLE: Se asocia el trastorno por deficit de atencion/hiperactividad con otras patologias prevalentes de la infancia?Objetivo. Revisar si el trastorno por deficit de atencion/hiperactividad (TDAH) se asocia con otras patologias medicas prevalentes de la edad pediatrica. Desarrollo. Se han seleccionado varias patologias pediatricas con el objetivo de revisar su asociacion con TDAH: en neumologia pediatrica, asma y otros procesos alergicos; en neurologia pediatrica, cefalea y convulsion febril; en gastroenterologia pediatrica, diarrea, estreñimiento, dolor abdominal, reflujo gastroesofagico e infeccion por Helicobacter pylori; en nefrologia pediatrica, enuresis; en cardiologia pediatrica, soplos y cardiopatias congenitas; en endocrinologia pediatrica, alteraciones tiroideas y obesidad, y en oftalmologia pediatrica, ametropia y estrabismo. Conclusion. Se han encontrado varios estudios que relacionan el TDAH con procesos alergicos, sobrepeso/obesidad, resistencia periferica a la hormona tiroidea, enuresis, convulsion febril, cefalea, cardiopatias congenitas, alteraciones oftalmologicas y caries, con algunas controversias y detalles por definir. Se puede concluir que son necesarios mas estudios interdisciplinarios para esclarecer las asociaciones y los mecanismos subyacentes implicados, con la finalidad de conocer mejor la compleja entidad TDAH y plantearse intervenciones preventivas, diagnosticas y terapeuticas en cuanto a sus comorbilidades se refiere.

Beneficios del mindfulness en mujeres embarazadas / Benefits of mindfulness in pregnant women

Este trabajo tiene el propósito de revisar el efecto de las intervenciones basadas en mindfulness sobre la salud mental perinatal. Se efectuó una búsqueda de la literatura publicada hasta septiembre 2019 en la base de datos Web of Science (WOS). Teniendo en cuenta los criterios de inclusión y exclusión y después de leer el título y abstracts de los artículos encontrados, se han seleccionado 26 de ellos, de los que se han escogido solo ocho por tratarse de ensayos controlados y aleatorizados (RCTs) que estudian datos de ansiedad, depresión, estrés percibido y mindfulness pre y post-intervención y con datos de seguimiento. Los resultados encontrados muestran que las intervenciones basadas en mindfulness (IBMs) son más eficaces que la asistencia sanitaria habitual (TAU) para la mujer embarazada a la hora de reducir la sintomatología depresiva, ansiosa y estrés percibido e incrementar sus niveles de mindfulness post-intervención. Para futuras investigaciones se consideraría interesante realizar el seguimiento de estas variables en el posparto e incluir otras como la calidad del vínculo madre-bebé, la adherencia a la lactancia materna y el desarrollo evolutivo del recién nacido.

This article is intended to review the effect of mindfulness-based interventions on perinatal mental health. A search of the literature published until September 2019 in the Web of Science (WOS) database was carried out. Taking into account the inclusion and exclusion criteria and after reading the title and abstracts of the articles found, 26 of them have been selected. Finally we only analyzed randomized controlled trials (RCTs) that show data on anxiety, depression, perceived stress and mindfulness before and after intervention and with follow-up data. The results found show that mindfulness-based interventions (IBMs) are more effective than the usual healthcare (TAU) that pregnant women receive for the reduction of depressive, anxious and perceived stress symptoms as well as increasing their post-intervention mindfulness levels. For future research, a postpartum follow-up would be considered interesting taking into account variables such as the quality of the mother-baby attachment, adherence to breastfeeding and the evolutionary development of the newborn.

Reprint of "Neurofeedback and standard pharmacological intervention in ADHD: a randomized controlled trial with six-month follow-up".

The present study is a randomized controlled trial that aims to evaluate the efficacy of Neurofeedback compared to standard pharmacological intervention in the treatment of attention deficit/hyperactivity disorder (ADHD). The final sample consisted of 23 children with ADHD (11 boys and 12 girls, 7-14 years old). Participants carried out 40 theta/beta training sessions or received methylphenidate. Behavioral rating scales were completed by fathers, mothers, and teachers at pre-, post-treatment, two-, and six-month naturalistic follow-up. In both groups, similar significant reductions were reported in ADHD functional impairment by parents; and in primary ADHD symptoms by parents and teachers. However, significant academic performance improvements were only detected in the Neurofeedback group. Our findings provide new evidence for the efficacy of Neurofeedback, and contribute to enlarge the range of non-pharmacological ADHD intervention choices. To our knowledge, this is the first randomized controlled trial with a six-month follow-up that compares Neurofeedback and stimulant medication in ADHD.

Prognostic factors of improvement in health-related quality of life in atomoxetine-treated children and adolescents with attention-deficit/hyperactivity disorder, based on a pooled analysis.

The objective of this study is to identify prognostic factors of treatment response to atomoxetine in improvement of health-related quality of life (HR-QoL), measured by the Child Health and Illness Profile-Child Edition Parent Report Form (CHIP-CE PRF) Achievement and Risk Avoidance domains, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Pooled data from 3 placebo-controlled trials and separate data from 3 open-label trials of atomoxetine in children and adolescents with ADHD were analyzed using logistic regression methods. Based on baseline impairment in the Achievement and/or Risk Avoidance domains (CHIP-CE PRF < 40 points), 2 subsamples of subjects were included. Treatment outcome was categorized as <5 points or ≥5 points increase in the CHIP-CE PRF Achievement and Risk Avoidance domains. Data of 190 and 183 subjects from the pooled sample, and 422 and 355 subjects from the open-label trials were included in the analysis of Achievement and Risk Avoidance domains. Baseline CHIP-CE subdomain scores proved to be the most robust prognostic factors for treatment outcome in both domains, based on data from the pooled sample of double-blind studies and from the individual open-label studies (odds ratios [OR] 0.74-1.56, p < 0.05; OR < 1, indicating a worse baseline score associated with worse odds of responding). Initial treatment response (≥25 % reduction in ADHD Rating Scale scores in the first 4-6 weeks) was another robust prognostic factor, based on data from the open-label studies (OR 2.99-6.19, p < 0.05). Baseline impairment in HR-QoL and initial treatment response can be early prognostic factors of atomoxetine treatment outcome in HR-QoL in children and adolescents with ADHD.

Cluster-randomized, controlled 12-month trial to evaluate the effect of a parental psychoeducation program on medication persistence in children with attention-deficit/hyperactivity disorder.

BACKGROUND: This multicenter, cluster-randomized, nonblinded study evaluated the effect of parental psychoeducation on medication persistence among children and adolescents with newly diagnosed attention-deficit/hyperactivity disorder (ADHD). METHODS: Patients received standard medication alone or medication plus a parental psychoeducation program, and were followed for 12 months. The primary endpoint was time to withdrawal or termination of medication due to any cause. Secondary endpoints included change in ADHD symptom severity, functional outcome, program satisfaction, and safety. RESULTS: A total of 208 patients completed the study, which was terminated early because recruitment had ceased. At 12 months, there was no significant difference between the psychoeducation and control groups in the proportion of patients who discontinued pharmacologic treatment (13.2% versus 14.3%, respectively; size effect -0.3, P=0.34; hazard ratio 0.72, 95% confidence interval 0.36-1.43). Psychoeducation was associated with a significantly greater improvement in ADHD symptoms but not in functional outcome. Parental satisfaction with psychoeducation was high, and satisfaction with pharmacologic treatment was significantly greater in the psychoeducation group. There were no safety concerns. CONCLUSION: No significant advantage for parental psychoeducation plus medication over medication alone in terms of time to medication withdrawal was observed. Psychoeducation had inconsistent but interesting effects on other outcomes.

Treatment response and remission in a double-blind, randomized, head-to-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit hyperactivity disorder.

OBJECTIVES: A secondary objective of this head-to-head study of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) was to assess treatment response rates in children and adolescents with attention-deficit hyperactivity disorder (ADHD) and an inadequate response to methylphenidate (MPH). The primary efficacy and safety outcomes of the study, SPD489-317 (ClinicalTrials.gov NCT01106430), have been published previously. METHODS: In this 9-week, double-blind, active-controlled study, patients aged 6-17 years with a previous inadequate response to MPH were randomized (1:1) to dose-optimized LDX (30, 50 or 70 mg/day) or ATX (patients <70 kg: 0.5-1.2 mg/kg/day, not to exceed 1.4 mg/kg/day; patients ≥70 kg: 40, 80 or 100 mg/day). Treatment response was a secondary efficacy outcome and was predefined as a reduction from baseline in ADHD Rating Scale IV (ADHD-RS-IV) total score of at least 25, 30 or 50 %. Sustained response was predefined as a reduction from baseline in ADHD-RS-IV total score (≥25, ≥30 or ≥50 %) or a Clinical Global Impressions (CGI)-Improvement (CGI-I) score of 1 or 2 throughout weeks 4-9. CGI-Severity (CGI-S) scores were also assessed, as an indicator of remission. RESULTS: A total of 267 patients were enrolled (LDX, n = 133; ATX, n = 134) and 200 completed the study (LDX, n = 99; ATX, n = 101). By week 9, significantly (p < 0.01) greater proportions of patients receiving LDX than ATX met the response criteria of a reduction from baseline in ADHD-RS-IV total score of at least 25 % (90.5 vs. 76.7 %), 30 % (88.1 vs. 73.7 %) or 50 % (73.0 vs. 50.4 %). Sustained response rates were also significantly (p < 0.05) higher among LDX-treated patients (ADHD-RS-IV ≥25, 66.1 %; ADHD-RS-IV ≥30, 61.4 %; ADHD-RS-IV ≥50, 41.7 %; CGI-I, 52.0 %) than among ATX-treated individuals (ADHD-RS-IV ≥25, 51.1 %; ADHD-RS-IV ≥30, 47.4 %; ADHD-RS-IV ≥50, 23.7 %; CGI-I, 39.3 %). Finally, by week 9, 60.7 % of patients receiving LDX and 46.3 % of those receiving ATX had a CGI-S score of 1 (normal, not at all ill) or 2 (borderline mentally ill), and greater proportions of patients in the LDX group than the ATX group experienced a reduction from baseline of at least one CGI-S category. CONCLUSIONS: Both LDX and ATX treatment were associated with high levels of treatment response in children and adolescents with ADHD and a previous inadequate response to MPH. However, within the parameters of the study, LDX was associated with significantly higher treatment response rates than ATX across all response criteria examined. In addition, higher proportions of patients in the LDX group than the ATX group had a CGI-S score of 1 or 2 by week 9, indicating remission of symptoms. Both treatments were generally well tolerated, with safety profiles consistent with those observed in previous studies.

Prevalence of oppositional defiant disorder in a sample of Spanish schoolchildren.

The aim of this study is to determine the prevalence rate of ODD in school age children, and analyze the variability of the prevalence rates per informant, according to the sources of information, sex, age, and level of agreement between teachers and parents. This is an epidemiological study conducted using a community sample extracted by means of multi-stage stratified sampling. The sample consisted of 1,295 children of both sexes from 6 to 8 years old. For diagnostic evaluation, the Oppositional Defiant Disorder Rating Scale (ODDRS-IV) was used. The estimated global prevalence of ODD, detected by all sources is 16.1%. But if we consider the percentage of subjects detected by only one informant, the prevalence rate is 9.5%. The prevalence according to teachers is 5.1% (95% CI = 3.88-6.31), according to fathers is 9% (95% CI = 7.38-10.54), and according to mothers is 9.7% (95% CI = 8.02-11.29). Teachers report more boys with ODD than girls. Results support the idea of high variability in ODD prevalence rates. Our findings suggest that parents are more prone to detect the disorder than teachers, and that boys present ODD more frequently than girls, only when they are evaluated by their teachers.

Neurofeedback and standard pharmacological intervention in ADHD: a randomized controlled trial with six-month follow-up.

The present study is a randomized controlled trial that aims to evaluate the efficacy of Neurofeedback compared to standard pharmacological intervention in the treatment of attention deficit/hyperactivity disorder (ADHD). The final sample consisted of 23 children with ADHD (11 boys and 12 girls, 7-14 years old). Participants carried out 40 theta/beta training sessions or received methylphenidate. Behavioral rating scales were completed by fathers, mothers, and teachers at pre-, post-treatment, two-, and six-month naturalistic follow-up. In both groups, similar significant reductions were reported in ADHD functional impairment by parents; and in primary ADHD symptoms by parents and teachers. However, significant academic performance improvements were only detected in the Neurofeedback group. Our findings provide new evidence for the efficacy of Neurofeedback, and contribute to enlarge the range of non-pharmacological ADHD intervention choices. To our knowledge, this is the first randomized controlled trial with a six-month follow-up that compares Neurofeedback and stimulant medication in ADHD.

Construct validity of ADHD/ODD rating scales: recommendations for the evaluation of forthcoming DSM-V ADHD/ODD scales.

Exploratory structural equation modeling (SEM) was applied to a multiple indicator (26 individual symptom ratings) by multitrait (ADHD-IN, ADHD-HI and ODD factors) by multiple source (mothers, fathers and teachers) model to test the invariance, convergent and discriminant validity of the Child and Adolescent Disruptive Behavior Inventory with 872 Thai adolescents and the ADHD Rating Scale-IV and ODD scale of the Disruptive Behavior Inventory with 1,749 Spanish children. Most of the individual ADHD/ODD symptoms showed convergent and discriminant validity with the loadings and thresholds being invariant over mothers, fathers and teachers in both samples (the three latent factor means were higher for parents than teachers). The ADHD-IN, ADHD-HI and ODD latent factors demonstrated convergent and discriminant validity between mothers and fathers within the two samples. Convergent and discriminant validity between parents and teachers for the three factors was either absent (Thai sample) or only partial (Spanish sample). The application of exploratory SEM to a multiple indicator by multitrait by multisource model should prove useful for the evaluation of the construct validity of the forthcoming DSM-V ADHD/ODD rating scales.

Fast vs. slow switching from stimulants to atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder.

OBJECTIVE: To compare fast versus slow switching from stimulants to atomoxetine (ATX) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS: This was a randomized, controlled, open-label study in 6-16-year-old ADHD patients, previously treated with stimulants and cross-titrated (fast switch, over 2 weeks, or slow switch, over 10 weeks) to ATX because of unsatisfactory response and/or adverse events. Study duration was 14 weeks with an ATX standard target dose of 1.2 mg/kg/day. Primary measure was the change from baseline in the investigator-rated ADHD-Rating Scale (ADHD-RS) at weeks 2 and 10. Secondary measures included Global Impression of Perceived Difficulties (GIPD) and Child Health and Illness Profile-Child Edition (CHIP-CE). RESULTS: The majority of the 111 patients were male (83.8%, n=93) and mean (SD) age was 11.5 (2.38) years. Mean baseline ADHD-RS total score was 36.0 in the fast and 38.0 in the slow group. Adjusted mean change after 2 weeks was -8.1 (-10.1; -6.1) in the fast and -8.0 (-9.9;-6.0) in the slow group (p=0.927), and after 10 weeks -15.0 (-17.4;-12.6) and -14.3 (-16.7;-12.0), respectively, (p=0.692). GIPD scores did not show differences between groups. Significant differences at week 10 were found in the CHIP-CE achievement domain favoring slow (p=0.036) and the comfort domain favoring fast cross-titration (p=0.030). No significant differences were found for adverse events, and differences for systolic blood pressure (BP) and weight were not considered clinically relevant. CONCLUSIONS: ADHD-RS and GIPD scores improved in both switching groups. No clinically relevant differences between fast and slow switching from stimulants to ATX were found.

Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study.

OBJECTIVES: The aim of this study was to compare the efficacy and safety of the prodrug psychostimulant lisdexamfetamine dimesylate (LDX) and the non-stimulant noradrenergic compound atomoxetine (ATX) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who had previously responded inadequately to methylphenidate (MPH). METHODS: This 9-week, head-to-head, randomized, double-blind, active-controlled study (SPD489-317; ClinicalTrials.gov NCT01106430) enrolled patients (aged 6-17 years) with at least moderately symptomatic ADHD and an inadequate response to previous MPH therapy. Patients were randomized (1:1) to an optimized daily dose of LDX (30, 50 or 70 mg) or ATX (patients <70 kg, 0.5-1.2 mg/kg with total daily dose not to exceed 1.4 mg/kg; patients ≥70 kg, 40, 80 or 100 mg). The primary efficacy outcome was time (days) to first clinical response. Clinical response was defined as a Clinical Global Impressions-Improvement (CGI-I) score of 1 (very much improved) or 2 (much improved). Secondary efficacy outcomes included the proportion of responders at each study visit and the change from baseline in ADHD Rating Scale (ADHD-RS-IV) and CGI-Severity scores. Tolerability and safety were assessed by monitoring treatment-emergent adverse events (TEAEs), height and weight, vital signs and electrocardiogram parameters. Endpoint was defined as the last post-baseline, on-treatment visit with a valid assessment. RESULTS: Of 267 patients randomized (LDX, n = 133; ATX, n = 134), 200 (74.9%) completed the study. The median time to first clinical response [95% confidence interval (CI)] was significantly shorter for patients receiving LDX [12.0 days (8.0-16.0)] than for those receiving ATX [21.0 days (15.0-23.0)] (p = 0.001). By week 9, 81.7% (95% CI 75.0-88.5) of patients receiving LDX had responded to treatment compared with 63.6% (95% CI 55.4-71.8) of those receiving ATX (p = 0.001). Also by week 9, the difference between LDX and ATX in least-squares mean change from baseline (95% CI) was significant in favour of LDX for the ADHD-RS-IV total score [-6.5 (-9.3 to -3.6); p < 0.001; effect size 0.56], inattentiveness subscale score [-3.4 (-4.9 to -1.8); p < 0.001; effect size 0.53] and the hyperactivity/impulsivity subscale score [-3.2 (-4.6 to -1.7); p < 0.001; effect size 0.53]. TEAEs were reported by 71.9 and 70.9% of patients receiving LDX and ATX, respectively. At endpoint, both treatments were associated with mean (standard deviation) increases in systolic blood pressure [LDX, +0.7 mmHg (9.08); ATX, +0.6 mmHg (7.96)], diastolic blood pressure [LDX, +0.1 mmHg (8.33); ATX, +1.3 mmHg (8.24)] and pulse rate [LDX, +3.6 bpm (10.49); ATX, +3.7 bpm (10.75)], and decreases in weight [LDX, -1.30 kg (1.806); ATX, -0.15 kg (1.434)]. CONCLUSIONS: LDX was associated with a faster and more robust treatment response than ATX in children and adolescents with at least moderately symptomatic ADHD who had previously responded inadequately to MPH. Both treatments displayed safety profiles consistent with findings from previous clinical trials.

[The influence of different diagnostic criteria and the culture on the prevalence of attention deficit hyperactivity disorder]. / Influencia de los diferentes criterios diagnosticos y la cultura en la prevalencia del trastorno por deficit de atencion/hiperactividad.

AIM: To compare the prevalence of attention deficit disorder and hyperactivity disorder (ADHD) using different diagnostic criteria (DSM-IV-TR versus ICD-10) and two specific scales based on DSM IV (ADHD-IV Rating Scales and SNAP-IV p90) in school-age children (6-12 years). PATIENTS AND METHOD: . A population-based study applying stratified multistage sample design (by courses), proportional to the type of school (public, private and enterd) and demographic areas (rural, city). From a target population of approximately 30 000 subjects a sample of 1509 children. RESULTS: The prevalence rates of ADHD were within the expected range: 3.6% (95% CI = 2.6-4.6%) using DSM-IV criteria, 1.2% (95% CI = 0.6-1.8%) using the ICD-10, 4.6% (95% CI = 3.5-5.7%) using ADHD Rating Scales-IV with a cut-off of 90 percentile 4.11% (95% CI = 3.2-5.1%) using the scale SNAP-IV. However, we found some differences in reference to gender and subtype according to the criteria and instrument used. CONCLUSIONS: We propose to use standard scales, scale by age, sex and evaluator that includes maturation and sociocultural factors help us draw conclusions about the true prevalence of ADHD.