Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome

Cleansing of the skin and hair is part of the daily routine of all neonates, infants, toddlers, children, and adolescents. Numerous soap and shampoo products are available to the consumer. The pediatrician is often asked to comment on the safety and efficacy of these products. Little information is available to help the pediatrician make a rational decision. The list of ingredients on the package are seldom useful and can be confusing. The theoretical and practical considerations leading to the addition of the major constituents of soaps and shampoos are reviewed and guidelines for the use of soaps and shampoos under normal circumstances and in a few selected conditions are suggested.

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Safety and efficacy of agomelatine in combination with psychosocial counselling in children and adolescents with major depressive disorder: a double-blind, randomised, controlled, phase 3 trial in nine countries

The Lancet Psychiatry ◽

10.1016/s2215-0366(21)00390-4 ◽

2021 ◽

Author(s):

Celso Arango ◽

Jan K Buitelaar ◽

Jörg M Fegert ◽

Valérie Olivier ◽

Pierre-François Pénélaud ◽

...

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Children And Adolescents ◽

Major Depressive ◽

Phase 3 ◽

Double Blind ◽

Safety And Efficacy ◽

Psychosocial Counselling ◽

Randomised Controlled

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Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials

CNS Spectrums ◽

10.1017/s1092852918001128 ◽

2018 ◽

Vol 24 (5) ◽

pp. 496-506 ◽

Cited By ~ 1

Author(s):

Sarah Atkinson ◽

Louise Thurman ◽

Sara Ramaker ◽

Gina Buckley ◽

Sarah Ruta Jones ◽

...

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Children And Adolescents ◽

Rating Scale ◽

Transition Period ◽

Extension Study ◽

Open Label ◽

Major Depressive ◽

Children’S Depression ◽

Flexible Dose

ObjectiveTwo similarly designed extension studies evaluated the long-term safety and tolerability of desvenlafaxine for the treatment of children and adolescents with major depressive disorder (MDD). Efficacy was evaluated as a secondary objective.MethodsBoth 6-month, open-label, flexible-dose extension studies enrolled children and adolescents who had completed one of two double-blind, placebo-controlled, lead-in studies. One lead-in study included a 1-week transition period prior to the extension study. Patients received 26-week treatment with flexible-dose desvenlafaxine (20–50 mg/d). Safety assessments included comprehensive psychiatric evaluations, vital sign assessments, laboratory evaluations, 12-lead electrocardiogram, physical examination with Tanner assessment, and Columbia-Suicide Severity Rating Scale. Adverse events (AEs) were collected throughout the studies. Efficacy was assessed using the Children’s Depression Rating Scale–Revised (CDRS-R).ResultsA total of 552 patients enrolled (completion rates: 66.4 and 69.1%). AEs were reported by 79.4 and 79.1% of patients in the two studies; 8.9 and 5.2% discontinued due to AEs. Treatment-emergent suicidal ideation or behavior was reported for 16.6 and 14.1% of patients in the two studies. Mean (SD) CDRS-R total score decreased from 33.83 (11.93) and 30.92 (10.20) at the extension study baseline to 24.31 (7.48) and 24.92 (8.45), respectively, at week 26.ConclusionDesvenlafaxine 20 to 50 mg/d was generally safe and well tolerated with no new safety signals identified in children and adolescents with MDD who received up to 6 months of treatment in these studies. Patients maintained the reduction in severity of depressive symptoms observed in all treatment groups at the end of the lead-in study.

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The prevalence of tic disorders in children and adolescents in Brazil

Arquivos de Neuro-Psiquiatria ◽

10.1590/0004-282x20140174 ◽

2014 ◽

Vol 72 (12) ◽

pp. 942-948 ◽

Cited By ~ 3

Author(s):

Helvio L. Alves ◽

Elizabeth M. A. B. Quagliato

Keyword(s):

Special Education ◽

Children And Adolescents ◽

Tourette Syndrome ◽

Special Education Students ◽

Tic Disorders ◽

Education Students ◽

Tic Disorder ◽

Item Questionnaire ◽

Chronic Tic Disorder

Tourette syndrome (TS) and tic disorders represent events of familiar magnitude characterized by involuntary movements and/or vocalization. To determine the prevalence of TS/tic disorders we studied a sample of 762 subjects (388 M, 374 F), between 1992 and 1997, age 6 to 43 years old, taken out of a population of 10,155 subjects (4,918 M, 5,237 F; age: 3-56 years old). A structured 4-item questionnaire, direct interview (multistaged), >1 yr follow-up, were used. 9,565 subjects (4,614 M, 4,951 F) sent back the questionnaires, 3,354 of these (1,671 M, 1,683 F) with positive answers to tics. 42 subjects (31 M, 11 F, age: 7-21 years old, mean: 11 years old) met the DSM-III-R criteria. The total minimal prevalence of TS is 0.43%, with a 3:1 ratio male/female. The minimal prevalence of chronic tic disorder is 2.27%. The total minimal prevalence for tic disorders at all is 2.91%. No special education students participation.

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