The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.
NCT ID: NCT01798459
Last Updated: 2015-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2013-02-28
2016-05-31
Brief Summary
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Patient population: 30 children diagnosed with attention deficit hyperactivity disorder. The subjects will be of all racial, ethnical and gender categories, ranging from 8 to 18 years of age.
Structure: the study is a randomized double blind crossover study. The subjects will complete a continuous performance test, the cambridge neuropsychological test automated Battery, before and after given methylphenidate or placebo on the first day of the study. On the second day of the study, the subjects will receive either methylphenidate or placebo based on what was given on the first day of the study and they will complete the same task.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
QUADRUPLE
Study Groups
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Methylphenidate
Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test.
Methylphenidate
Placebo
Placebo is given before performing a continuous performance test.
No interventions assigned to this group
Interventions
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Methylphenidate
Eligibility Criteria
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Inclusion Criteria
* Children aged 8-18 years
Exclusion Criteria
* Schizophrenia
* Bipolar disorder
* Current depressive episode
* Current Anxiety disorder
* Drug use during the past 6 months
8 Years
18 Years
ALL
Yes
Sponsors
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Shalvata Mental Health Center
OTHER
Responsible Party
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Maya Kritchman Lupo
Resident
Principal Investigators
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Maya Kritchman Lupo, MD
Role: PRINCIPAL_INVESTIGATOR
Shalvata Mental Health Center
Locations
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Shalvata
Hod HaSharon, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.
Kritchman M, Koubi M, Mimouni Bloch A, Bloch Y. Effect of Methylphenidate on State Anxiety in Children With ADHD-A Single Dose, Placebo Controlled, Crossover Study. Front Behav Neurosci. 2019 May 15;13:106. doi: 10.3389/fnbeh.2019.00106. eCollection 2019.
Other Identifiers
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0009-12-SHA
Identifier Type: -
Identifier Source: org_study_id
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