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The purpose of the study is to explore the effect of methylphenidate on state anxiety in children with attention deficit hyperactivity disorder.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate | Active Comparator | Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test. |
|
| Placebo | Placebo Comparator | Placebo is given before performing a continuous performance test. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| State anxiety | State anxiety will be measured by the Spielberger's state anxiety inventory | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | Cognitive function will be measured by the cambridge neuropsychological test automated battery | 1 year |
| Patient's perspective | Patient's perspective will be measured by questionnaires assessing treatment adherence issues and patient's view regarding the use of placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Kritchman-Lupo, MD | Contact | 972-9-7478644 | maiakr@clalit.org.il; mayakri@gmail.com | |
| Yuval Bloch, MD | Contact | 972-9-7478510 | yuvalbl@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Maya Kritchman Lupo, MD | Shalvata Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shalvata | Recruiting | Hod HaSharon | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41342306 | Derived | Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling 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. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4. | |
| 36971690 |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 1 year |
| 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. |
| 31156406 | Derived | 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. |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |