Assessment the Efficacy of Atomoxetine in Autism Spectrum Disorders: A Randomized, Double-Blind, Placebo-Controlled Trial

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Eslamzadeh Mahbobeh; HEBRANI PARIA; BEHDANI FATEMEH; Dadgar Moghadam Malihee; PANAGHI LEILI; Mirzadeh Mansoureh; ARABGOL FARIBA

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Journal: Iranian Journal of Psychiatry and Behavioral Sciences Year:2018 | Volume:12 | Issue:2 Page(s): 0-0

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Title

Assessment the Efficacy of Atomoxetine in Autism Spectrum Disorders: A Randomized, Double-Blind, Placebo-Controlled Trial

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Keywords

Autism Spectrum Disorders

Atomoxetine Hydrochloride

Risperidone

Abstract

Background: Autism Spectrum Disorders (ASD) are early onset conditions characterized by significant impairment in social interaction and communication. Objectives: The purpose of this study was the assessment of Atomoxetine effectiveness and tolerability in the treatment of autistic features in patients with ASD. Methods: A total of 44 children, aged 6 to 17 years, diagnosed with ASD, enrolled in a 8 week randomized clinical trial. The study conducted at the outpatient clinic of Ibne-sina hospital and Dr. Sheikh hospital affiliated to the Mashhad Medical University in Iran, between August 2015 to September 2016. Subjects were randomly allocated to Atomoxetine (0. 5 to 1. 2 mg/kg/day) plus Risperidone or Placebo plus Risperidone. The primary outcome was assessed by the childhood autism rating scale (CARS) and clinical global impression (CGI). Patients were evaluated at baseline, 4 weeks and 8 weeks after the administration of the drug. Mixed ANOVA test is used for the outcome of evaluation. The clinical trial registration number is: IRCT2016022826802N1. Results: Atomoxetine augmentation comparison to placebo augmentation showed significant improvement in global impression and severity index in CGI, and also in total score of CARS and 7 subscales of CARS including relationship to people, emotional response, body use, listening response, fear and nervousness, nonverbal communication, and activity level (all P value 0. 05). The most common adverse effects of Atomoxetine were mood change, irritability, and GI disturbance. Conclusions: The results showed that Atomoxetine add-on therapy may be effective in symptoms of ASD while adverse effects tend to subside. The authors suggest further studies for clarifying this conclusion.

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APA: Copy

Eslamzadeh, Mahbobeh, HEBRANI, PARIA, BEHDANI, FATEMEH, Dadgar Moghadam, Malihee, PANAGHI, LEILI, Mirzadeh, Mansoureh, & ARABGOL, FARIBA. (2018). Assessment the Efficacy of Atomoxetine in Autism Spectrum Disorders: A Randomized, Double-Blind, Placebo-Controlled Trial. IRANIAN JOURNAL OF PSYCHIATRY AND BEHAVIORAL SCIENCES (IJPBS), 12(2), 0-0. SID. https://sid.ir/paper/312222/en

Vancouver: Copy

Eslamzadeh Mahbobeh, HEBRANI PARIA, BEHDANI FATEMEH, Dadgar Moghadam Malihee, PANAGHI LEILI, Mirzadeh Mansoureh, ARABGOL FARIBA. Assessment the Efficacy of Atomoxetine in Autism Spectrum Disorders: A Randomized, Double-Blind, Placebo-Controlled Trial. IRANIAN JOURNAL OF PSYCHIATRY AND BEHAVIORAL SCIENCES (IJPBS)[Internet]. 2018;12(2):0-0. Available from: https://sid.ir/paper/312222/en

IEEE: Copy

Mahbobeh Eslamzadeh, PARIA HEBRANI, FATEMEH BEHDANI, Malihee Dadgar Moghadam, LEILI PANAGHI, Mansoureh Mirzadeh, and FARIBA ARABGOL, “Assessment the Efficacy of Atomoxetine in Autism Spectrum Disorders: A Randomized, Double-Blind, Placebo-Controlled Trial,” IRANIAN JOURNAL OF PSYCHIATRY AND BEHAVIORAL SCIENCES (IJPBS), vol. 12, no. 2, pp. 0–0, 2018, [Online]. Available: https://sid.ir/paper/312222/en

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