The safety of agomelatine in standard medical practice in depressed patients: A 26-week international multicentre cohort study.

OBJECTIVE: The present observational cohort study documented the safety of agomelatine in current medical practice in out-patients suffering from major depressive disorder. METHOD: The 6-month evolution of agomelatine-treated patients was assessed with a focus on safety (emergent adverse events, liver acceptability), severity of depression using the Clinical Global Impression Severity (CGI-S) score, and functioning measured by the Sheehan Disability Scale (SDS). RESULTS: A total of 8453 depressed patients from 761 centres in 6 countries were analysed (female: 67.7%; mean age: 49.1 ± 14.8 years). Adverse events reported were in accordance with the known safety profile of agomelatine. Cutaneous events were reported in 1.7% of the patients and increased hepatic transaminases values were reported in 0.9 % of the patients. The incidence of events related to suicide/self-injury was 1.0%. Two completed suicides, not related to the study drug, were reported. CGI-S total scores and SDS sub-scores improved and numbers of days lost or underproductive decreased over the treatment period. CONCLUSIONS: In standard medical practice, agomelatine treatment was associated with a low incidence of side effects. No unexpected events were reported. A decrease in the severity of the depressive episode and improved functioning were observed. TRIAL REGISTRATION NAME: Observational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients. A prospective, observational (non-interventional), international, multicentre cohort study. TRIAL REGISTRATION NUMBER: ISRCTN53570733.

Sleep study in Disruptive Mood Dysregulation Disorder and Bipolar children.

INTRODUCTION: Decreased need for sleep has been proposed as a core symptom of mania and it has been associated with the pathogenesis of Bipolar Disorder. The emergence of Disruptive Mood Dysregulation Disorder (DMDD) as a new diagnostic has been controversial and much has been speculated about its relationship with the bipolar spectrum. REM sleep fragmentation could be a biomarker of affective disorders and it would help us to differentiate them from other disorders. METHOD: Polysomnographic cross-sectional study of children with DMDD, bipolar disorder and Attention Deficit Hyperactivity Disorder (ADHD). All participants underwent a psychiatric semi-structured interview to obtain the diagnosis, comorbidities and primary sleep disorders. DMDD’s sample was performed following DSM5 criteria. GOALS: Perform polysomnography in a sample of bipolar, DMDD and ADHD children and compare their profiles to provide more evidence about the differences or similarities between bipolar disorder and DMDD. RESULTS: Bipolar group had the highest REM density values while ADHD had the lowest. REM density was not statiscally different between bipolar phenotypes. REM density was associated with antidepressant treatment, episodes of REM and their interaction. REM latency was associated with antipsychotic treatment and school performance. Bipolar patients had higher scores on the depression scale than DMDD and ADHD groups. CONCLUSIONS: No significant differences between the two compared affective disorders were found. However there were differences in REM density between bipolar and ADHD groups. REM sleep study could provide a new theoretical framework to better understand the pathogenesis of pediatric bipolar disorder.

Estudio del sueño en niños con Trastorno de Disregulación Disruptivo del Estado de Ánimo y Bipolares / Sleep study in Disruptive Mood Dysregulation Disorder and Bipolar children

Introducción. La disminución de la necesidad de sueño ha sido propuesta como síntoma nuclear de manía y ha sido relacionada con la etiopatogenia del Trastorno Bipolar. La irrupción del Trastorno de Disregulación Disruptivo del Estado de Ánimo (TDDEA) como nueva categoría diagnóstica en el DSM5 ha sido controvertida y mucho se ha especulado acerca de su relación con el espectro bipolar. La fragmentación del sueño REM podría ser un biomarcador de los trastornos afectivos y ayudarnos a diferenciarlos de otros trastornos. Metodología. Estudio transversal polisomnográfico en niños con TDDEA, bipolaridad y con Trastorno por Déficit de Atención e Hiperactividad (TDAH). A todos los participantes se les realizó una entrevista psiquiátrica semi-estructurada para la obtención del diagnóstico, la detección de posibles comorbilidades y de los trastornos primarios del sueño. La obtención de la muestra TDDEA se realizó siguiendo los criterios recomendados por el DSM5. Objetivos. Realizar un estudio polisomnográfico en una muestra de niños TDDEA, Trastorno Bipolar Pediátrico (TBP) y TDAH y comparar sus perfiles, para aportar mayor evidencia acerca de las diferencias o semejanzas entre el TBP y el TDDEA. Resultados. El grupo bipolar presentó los valores más altos de densidad REM mientras que el grupo TDAH presentó los más bajos. La densidad REM no presentó diferencias estadísticamente significativas entre los distintos fenotipos bipolares. La densidad REM se asoció con el tratamiento antidepresivo, los episodios de REM y su interacción. La latencia REM se asoció con el tratamiento antipsicótico y el rendimiento escolar. Los pacientes bipolares presentaron mayores puntuaciones en la escala de depresión que los grupos TDDEA y TDAH. Conclusiones. No se encontraron diferencias significativas entre los dos trastornos afectivos comparados aunque sí se hallaron diferencias en la densidad REM entre los grupos bipolar y TDAH. El estudio del sueño REM podría proporcionar un nuevo marco teórico para comprender mejor la etiopatogenia del trastorno bipolar pediátrico

Introduction. Decreased need for sleep has been proposed as a core symptom of mania and it has been associated with the pathogenesis of Bipolar Disorder. The emergence of Disruptive Mood Dysregulation Disorder (DMDD) as a new diagnostic has been controversial and much has been speculated about its relationship with the bipolar spectrum. REM sleep fragmentation could be a biomarker of affective disorders and it would help us to differentiate them from other disorders. Method. Polysomnographic cross-sectional study of children with DMDD, bipolar disorder and Attention Deficit Hyperactivity Disorder (ADHD). All participants underwent a psychiatric semi-structured interview to obtain the diagnosis, comorbidities and primary sleep disorders. DMDD’s sample was performed following DSM5 criteria. Goals. Perform polysomnography in a sample of bipolar, DMDD and ADHD children and compare their profiles to provide more evidence about the differences or similarities between bipolar disorder and DMDD. Results. Bipolar group had the highest REM density values while ADHD had the lowest. REM density was not statiscally different between bipolar phenotypes. REM density was associated with antidepressant treatment, episodes of REM and their interaction. REM latency was associated with antipsychotic treatment and school performance. Bipolar patients had higher scores on the depression scale than DMDD and ADHD groups. Conclusions. No significant differences between the two compared affective disorders were found. However there were differences in REM density between bipolar and ADHD groups. REM sleep study could provide a new theoretical framework to better understand the pathogenesis of pediatric bipolar disorder

[Olanzapine long-acting post-injection syndrome: a case report and brief review]. / Síndrome post-inyección por olanzapina de liberación retardada: Breve revisión a propósito de un caso.

The introduction of long-acting injectable atypical antipsychotics has ensured adherence to treatment in patients with low awareness of the disorder, with an acceptable rate of side effects. In the case of long acting olanzapine injection in particular, has particular relevance the existence of a special side-effect called post-injection syndrome. This rare side effect consisting in the presence of symptoms of olanzapine overdose after intramuscular administration of medication has led to restrictions on the use of the drug and the need for patient observation for three hours after each injection. We report a case of postinjection syndrome, to our knowledge, the first in Spain since the commercialization of Zypadhera. As in most cases described in the literature have symptoms of overdosage of olanzapine (dysarthria, sedation, fatigue, etc.) that are selflimiting without any therapeutic measure and are accompanied by supratherapeutic plasma levels of olanzapine.

Síndrome post-inyección por olanzapina de liberación retardada: Breve revisión a propósito de un caso / Olanzapine long-acting post-injection syndrome: A case report and brief review

La introducción de los antipsicóticos atípicos de liberación retardada ha permitido asegurar la adherencia al tratamiento en aquellos pacientes con baja conciencia de trastorno, con una tasa aceptable de efectos secundarios. En el caso de la olanzapina de liberación retardada en concreto, tiene especial relevancia la existencia del llamado Síndrome post-inyección. Este efecto secundario poco común consistente en la presencia de síntomas de sobredosis de olanzapina tras la administración intramuscular de la medicación ha supuesto restricción del uso del medicamento y la necesidad de observación del paciente durante tres horas después de cada inyección. Se presenta un caso de Síndrome post-inyección, a nuestro conocimiento, el primero en España desde la comercialización de Zypadhera. Al igual que en la mayoría de casos descritos en la bibliografía el paciente presenta síntomas de sobredosificación de olanzapina (disartria, sedación, astenia, etc.) que se auto limitan sin medida terapéutica alguna y se acompañan de niveles plasmáticos supraterapéuticos de olanzapina(AU)

The introduction of long-acting injectable atypical antipsychotics has ensured adherence to treatment in patients with low awareness of the disorder, with an acceptable rate of side effects. In the case of long acting olanzapine injection in particular, has particular relevance the existence of a special side-effect called post-injection syndrome. This rare side effect consisting in the presence of symptoms of olanzapine overdose after intramuscular administration of medication has led to restrictions on the use of the drug and the need for patient observation for three hours after each injection. We report a case of postinjection syndrome, to our knowledge, the first in Spain since the commercialization of Zypadhera. As in most cases described in the literature have symptoms of over dosage of olanzapine (dysarthria, sedation, fatigue, etc.) that are selflimiting without any therapeutic measure and are accompanied by supra therapeutic plasma levels of olanzapine(AU)