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autism and aripiprazole

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1. Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder

Additional relevant MeSH terms: Layout table for MeSH terms Disease Autistic Disorder Pathologic Processes Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders Pharmaceutical Solutions Aripiprazole Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action (...) Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one

2018 Clinical Trials

2. Aripiprazole for Irritability in Asian Children and Adolescents with Autistic Disorder: A 12-Week, Multinational, Multicenter, Prospective Open-Label Study. (Abstract)

Aripiprazole for Irritability in Asian Children and Adolescents with Autistic Disorder: A 12-Week, Multinational, Multicenter, Prospective Open-Label Study. We investigated the effectiveness and tolerability of aripiprazole in the treatment of irritability in Asian children and adolescents (6-17 years) with autistic disorder in a 12-week, multinational, multicenter, open-label study.Sixty-seven subjects (10.0 ± 3.1 years old, 52 boys) were enrolled and treated with flexibly dosed aripiprazole (...) and no serious adverse event related to aripiprazole treatment was noted.Our results suggest that aripiprazole is effective and generally tolerable in the treatment of irritability in Asian children and adolescents with autistic disorder. Further studies with larger sample sizes and longer treatment durations are required.

2018 Journal of Child and Adolescent Psychopharmacology

3. Aripiprazole Mylan - aripiprazole

undesirable effects including EPS related events, somnolence, fatigue and weight gain. Doses higher than 10 mg/day should therefore only be used in exceptional cases and with close clinical monitoring. Younger patients are at increased risk of experiencing adverse events associated with aripiprazole. Therefore, Aripiprazole Mylan is not recommended for use in patients below 13 years of age. Aripiprazole Mylan EMA/CHMP/705827/2014 Page 8/39 Irritability associated with autistic disorder: the safety (...) Aripiprazole Mylan - aripiprazole 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged. 20 November 2014 EMA/CHMP/705827/2014 Committee for Medicinal Products for Human Use (CHMP) Withdrawal Assessment report Aripiprazole Mylan

2015 European Medicines Agency - EPARs

4. Aripiprazole

/day or aripiprazole 15 mg/day for 6 weeks. Outcomes included change from baseline to week 6 in the Positive and Negative Syndrome Scale total score, Barratt Impulsiveness Scale 11-item 2016 17. Head-to-Head Comparison of Aripiprazole and Risperidone in the Treatment of ADHD Symptoms in Children with Autistic Spectrum Disorder and ADHD: A Pilot, Open-Label, Randomized Controlled Study. 27278054 2016 06 25 2016 12 13 2016 12 30 1179-2019 18 4 2016 Aug Paediatric drugs Paediatr Drugs Head-to-Head (...) Comparison of Aripiprazole and Risperidone in the Treatment of ADHD Symptoms in Children with Autistic Spectrum Disorder and ADHD: A Pilot, Open-Label, Randomized Controlled Study. 319-29 (...) and aripiprazole for treating ADHD symptoms in patients with both ASD and ADHD over the course of 24 weeks of treatment. Patients (n = 44) were randomly assigned to start treatment with risperidone (22 patients) or aripiprazole (22 patients). Children were evaluated before starting treatment (T0), and after 12

2018 Trip Latest and Greatest

5. Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Additional relevant MeSH terms: Layout table for MeSH terms Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders Aripiprazole Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Dopamine Agonists Dopamine Agents (...) Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Post

2017 Clinical Trials

6. Aripiprazole Zentiva

Active Pharmaceutical Ingredient AR Assessment Report ARP aripiprazole ASD autism spectrum disorders ASM Active Substance Manufacturer ASMF Active Substance Master File = Drug Master File AUC area under the curve AUC0-8 area under the curve from time zero to infinity BE Bioequivalence BMI body mass index BP British Pharmacopoeia BPRS brief psychiatric rating scale CEP Certificate of Suitability of the Ph.Eur. CGI clinical global impression CGI-BV clinical global impression bipolar version CGI-S (...) Aripiprazole Zentiva 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 23 April 2015 EMA/CHMP/232319/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Aripiprazole Zentiva International non-proprietary name: aripiprazole Procedure No. EMEA/H/C/003899/0000 Note Assessment report as adopted by the CHMP

2015 European Medicines Agency - EPARs

7. Head-to-Head Comparison of Aripiprazole and Risperidone in the Treatment of ADHD Symptoms in Children with Autistic Spectrum Disorder and ADHD: A Pilot, Open-Label, Randomized Controlled Study. (Abstract)

Head-to-Head Comparison of Aripiprazole and Risperidone in the Treatment of ADHD Symptoms in Children with Autistic Spectrum Disorder and ADHD: A Pilot, Open-Label, Randomized Controlled Study. Autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) are frequently overlapping neurodevelopmental disorders. Individuals in whom the disorders are comorbid show more severe impairment because of deficits in the processing of social situations, adaptive functioning (...) , and executive control than individuals with either disorder alone.This open-label pilot study aimed to evaluate and compare the efficacy and tolerability of risperidone and aripiprazole for treating ADHD symptoms in patients with both ASD and ADHD over the course of 24 weeks of treatment.Patients (n = 44) were randomly assigned to start treatment with risperidone (22 patients) or aripiprazole (22 patients). Children were evaluated before starting treatment (T0), and after 12 weeks (T1) and 24 weeks (T2

2016 Paediatric Drugs Controlled trial quality: uncertain

8. Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study. Full Text available with Trip Pro

Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study. We evaluated the efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents (6-17 years) with autism spectrum disorder (ASD) in a randomized, double-blind, placebo-controlled 8-week study in Japan. Patients received flexibly dosed aripiprazole (1-15 mg/day) or placebo. Ninety-two patients (...) were randomized to placebo (n = 45) or aripiprazole (n = 47). Aripiprazole produced a significant improvement in the mean parent/caregiver-rated Aberrant Behavior Checklist Japanese Version irritability subscale score relative to placebo from week 3 through week 8. Administration of aripiprazole provided significantly greater improvement in the mean clinician-rated Clinical Global Impression-Improvement scores than placebo from week 2 through week 8. All patients randomized to aripiprazole

2016 Child psychiatry and human development Controlled trial quality: uncertain

9. Aripiprazole Toxicity With a Biphasic Course of Somnolence. (Abstract)

Aripiprazole Toxicity With a Biphasic Course of Somnolence. Aripiprazole is an atypical antipsychotic with partial agonism at dopamine and serotonin receptors. In pediatrics, it is approved to treat irritability associated with autistic disorder along with other neuropsychological conditions. Compared with other atypical antipsychotics, it has a favorable side effect profile, but overdose experience is limited.A 3-year-old drug-naive patient accidentally ingested 200 mg of aripiprazole (...) . This ingestion resulted in immediate lethargy with brief improvement 16 hours after ingestion and subsequent decline 2 hours later. Patient returned to baseline 72 hours after ingestion.Unlike previous case reports, this patient displayed a biphasic course of somnolence. Previous reports have described delayed onset and prolonged sedation in response to an aripiprazole overdose. Current recommendations regarding monitoring after ingestion do not account for possible worsening of symptoms after improvement.It

2019 Pediatric Emergency Care

10. Interventions Targeting Sensory Challenges in Children with Autism Spectrum Disorder - An Update

: 21220213.X-1 D-55 642. Ghanizadeh A. Can tactile sensory processing differentiate between children with autistic disorder and asperger's disorder? Innov Clin Neurosci. 2011 May;8(5):25-30. PMID: 21686145.X-1 643. Ghanizadeh A. A novel hypothesized clinical implication of zonisamide for autism...Ann Neurol. 2010 Feb;67(2):239- 49. Annals of Neurology. 2011;69(2):426- 1p. doi: 10.1002/ana.22153. PMID: 104841194. Language: English. Entry Date: 20110527. Revision Date: 20150711. Publication Type: Journal (...) : 104685451. Language: English. Entry Date: 20110930. Revision Date: 20150711. Publication Type: Journal Article.X-1, X-2 668. Hellings JA, Boehm D, Yeh HW, et al. Long-term aripiprazole in youth with developmental disabilities including autism. Journal of Mental Health Research in Intellectual Disabilities. 2011 2015-12- 09;4(1):40-52. doi: http://dx.doi.org/10.1080/19315864.2010.54 2274. PMID: 872590596; 2011-05041- 003.X-1, X-3 669. Hepburn SL, Moody EJ. Diagnosing Autism in Individuals with Known

2017 Effective Health Care Program (AHRQ)

11. Assessment, diagnosis and interventions for autism spectrum disorders

. The inclusion of adults is in response to the increasing understanding that autism spectrum disorder (ASD) is a lifelong condition in which the core features of ASD persist whilst manifesting differently according to different age stages. Depending on the severity of autistic difficulties, ASD may not be evident as a presentation throughout preschool, primary, or secondary school years or in adulthood. It may not be recognised because of associated coexisting conditions. Variable environmental factors (...) on cognition. A study conducted in a gender clinic in London reported that among the 92 participants the prevalence of autistic traits, based on assessment with the Autism Spectrum Quotient (AQ) was 5.5% (3 male to female and 2 female to male transsexuals) compared to reports of clinical diagnoses of 0.5–2.0% in the general population. 49 Further indicators of possible ASD in adults are listed in Annex 2. Healthcare professionals should be aware of indicators for ASD in adults presenting with other

2016 SIGN

12. Behavioral Mechanisms That Depend on Dopamine and Serotonin in Caenorhabditis elegans Interact With the Antipsychotics Risperidone and Aripiprazole Full Text available with Trip Pro

genes. Risperidone and aripiprazole are a class of drugs known as atypical antipsychotics commonly used to treat schizophrenia, bipolar disorder, and irritability associated with autism. Risperidone is an antagonist of the dopamine D2 and serotonin 5-HT2A receptors. Aripiprazole functions as a partial agonist of the dopamine D2 receptor and as a partial agonist and antagonist of 5-HT1A and 5-HT2A serotonin receptors, respectively. Our results show that risperidone and aripiprazole alter the touch (...) Behavioral Mechanisms That Depend on Dopamine and Serotonin in Caenorhabditis elegans Interact With the Antipsychotics Risperidone and Aripiprazole The neurotransmitters dopamine and serotonin participate in specific behavioral neuromuscular mechanisms in the nematode Caenorhabditis elegans. Dopamine is involved in the gentle touch response and serotonin in the pharyngeal pumping rate. In its genome, the worm presents genes encoding dopamine and serotonin receptors orthologous to those of human

2018 Journal of Experimental Neuroscience

13. Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome

Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one (...) or more studies before adding more. Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03487783 Recruitment Status : Recruiting

2018 Clinical Trials

14. A randomized controlled trial investigating the safety and efficacy of aripiprazole in the long-term maintenance treatment of pediatric patients with irritability associated with autistic disorder. (Abstract)

A randomized controlled trial investigating the safety and efficacy of aripiprazole in the long-term maintenance treatment of pediatric patients with irritability associated with autistic disorder. To evaluate the efficacy and safety of aripiprazole versus placebo in preventing relapse of irritability symptoms associated with autistic disorder in pediatric patients.This multicenter, double-blind, randomized, placebo-controlled, relapse-prevention trial enrolled patients (6-17 years) who met (...) the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DMS-IV-TR) criteria for autistic disorder and who also had serious behavioral problems (ie, tantrums, aggression, self-injurious behavior, or a combination of these behavioral problems) between March 2011 and June 2012. In phase 1, single-blind aripiprazole was flexibly dosed (2-15 mg/d) for 13-26 weeks. Patients with a stable response (≥ 25% decrease in Aberrant Behavior Checklist-irritability subscale score

2014 Journal of Clinical Psychiatry Controlled trial quality: predicted high

15. Aripiprazole Decreases Irritability in 12 out of 14 Youth with Autism Spectrum Disorders Full Text available with Trip Pro

Aripiprazole Decreases Irritability in 12 out of 14 Youth with Autism Spectrum Disorders 24828130 2015 10 22 2018 11 13 1557-8992 24 6 2014 Aug Journal of child and adolescent psychopharmacology J Child Adolesc Psychopharmacol Aripiprazole decreases irritability in 12 out of 14 youth with autism spectrum disorders. 357-9 10.1089/cap.2013.0143 Maloney Ann A Department of Psychiatry, UMASS Medical School , Worcester, Massachusetts. Mick Eric O EO Frazier Jean J eng P30HD004147 HD NICHD NIH HHS (...) United States Clinical Trial Letter Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't 2014 05 14 United States J Child Adolesc Psychopharmacol 9105358 1044-5463 0 Antipsychotic Agents 0 Piperazines 0 Quinolones 82VFR53I78 Aripiprazole IM Adolescent Antipsychotic Agents therapeutic use Aripiprazole Child Child Development Disorders, Pervasive drug therapy physiopathology Female Humans Irritable Mood drug effects Male Piperazines therapeutic use Quinolones therapeutic use Treatment

2014 Journal of Child and Adolescent Psychopharmacology

16. A randomized controlled trial investigating the safety and efficacy of aripiprazole in the long-term maintenance treatment of pediatric patients with irritability associated with autistic disorder. (Abstract)

A randomized controlled trial investigating the safety and efficacy of aripiprazole in the long-term maintenance treatment of pediatric patients with irritability associated with autistic disorder. To evaluate the efficacy and safety of aripiprazole versus placebo in preventing relapse of irritability symptoms associated with autistic disorder in pediatric patients.This multicenter, double-blind, randomized, placebo-controlled, relapse-prevention trial enrolled patients (6-17 years) who met (...) the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DMS-IV-TR) criteria for autistic disorder and who also had serious behavioral problems (ie, tantrums, aggression, self-injurious behavior, or a combination of these behavioral problems) between March 2011 and June 2012. In phase 1, single-blind aripiprazole was flexibly dosed (2-15 mg/d) for 13-26 weeks. Patients with a stable response (≥ 25% decrease in Aberrant Behavior Checklist-irritability subscale score

2014 Journal of Clinical Psychiatry Controlled trial quality: predicted high

17. A Head-to-Head Comparison of Aripiprazole and Risperidone for Safety and Treating Autistic Disorders, a Randomized Double Blind Clinical Trial. Full Text available with Trip Pro

A Head-to-Head Comparison of Aripiprazole and Risperidone for Safety and Treating Autistic Disorders, a Randomized Double Blind Clinical Trial. Aripiprazole and risperidone are the only FDA approved medications for treating irritability in autistic disorder, however there are no head-to-head data comparing these agents. This is the first prospective randomized clinical trial comparing the safety and efficacy of these two medications in patients with autism spectrum disorders. Fifty nine (...) children and adolescents with autism spectrum disorders were randomized to receive either aripiprazole or risperidone for 2 months. The primary outcome measure was change in Aberrant Behavior Checklist (ABC) scores. Adverse events were assessed. Aripiprazole as well as risperidone lowered ABC scores during 2 months. The rates of adverse effects were not significantly different between the two groups. The safety and efficacy of aripiprazole (mean dose 5.5 mg/day) and risperidone (mean dose 1.12 mg/day

2014 Child psychiatry and human development Controlled trial quality: uncertain

18. Autism: Should My Child Take Medicine for Challenging Behavior?

child’s behavior. ? Using this decision aid can help you… • Learn about autism and common problem behaviors • Learn about the possible benefits and possible risks of medicine • Make clear what is important to you in making a decision about medicine • Make a decision about whether to have your child take medicine for behavior *For the purposes of this decision aid, the term “autism” will be used to describe children with all types of Autism Spectrum Disorders, including Autistic Disorder, Asperger (...) Program. ADDITIONAL INFORMATION FREQUENTLY ASKED QUESTIONS ABOUT AUTISM ? What is autism? Autism is a general term used to describe a group of developmental disorders known as Pervasive Developmental Disorders (PDD) or Autism Spectrum Disorders (ASD). Disorders in this group include Autistic Disorder, Pervasive Developmental Disorder, Not Otherwise Specified (PDD-NOS) and Asperger Disorder Many people refer to this group as Autism Spectrum Disorders (ASD). In this decision aid, the term autism is used

2019 OHRI

19. Pharmacotherapy of Autism Spectrum Disorder: Results from the Randomized BAART Clinical Trial. Full Text available with Trip Pro

Pharmacotherapy of Autism Spectrum Disorder: Results from the Randomized BAART Clinical Trial. The objective of this trial-Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)-was to provide support and guidance for an evidence-based approach for the selection and monitoring of initial pharmacotherapy in patients with autism by assessing predictors of efficacy, tolerability, and safety.Randomized, double-blind, parallel-group study.Three academic medical centers and a single (...) private pediatric practice.Eighty children or adolescents (aged 6-17 years) with autistic disorder were enrolled, and 61 patients were randomized to study drug. Of those patients, 51 completed the 10-week trial, and 31 completed an optional 12-week blinded extension phase.All patients were treated with 2 weeks of placebo before random assignment to receive aripiprazole (31 patients) or risperidone (30 patients) for 10 weeks. Sixteen placebo responders (20%) were excluded from further analysis. Drug

2019 Pharmacotherapy Controlled trial quality: uncertain

20. Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. Full Text available with Trip Pro

Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. The purpose of this study was to evaluate the impact of prior antipsychotic exposure (PAE) on safety and tolerability outcomes in pediatric subjects receiving aripiprazole treatment.This study was a post-hoc analysis of pooled data from two 8-week, double-blind, randomized, placebo-controlled studies evaluating aripiprazole (...) for the treatment of irritability in pediatric subjects with autistic disorder, aged 6-17 years. Subjects were stratified by PAE; adverse events (AEs), and changes in weight, and metabolic measures were evaluated. For subjects receiving aripiprazole, regardless of PAE, baseline weight, age, gender, and symptom severity were evaluated in a regression model predicting body weight change.Of 316 randomized subjects, 259 (82.0%) were antipsychotic naïve (AN) and 57 (18.0%) had a PAE. Aripiprazole-treated AN subjects

2013 Journal of Child and Adolescent Psychopharmacology Controlled trial quality: predicted high

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