The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.
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|ClinicalTrials.gov Identifier: NCT01798459|
Recruitment Status : Unknown
Verified March 2015 by Maya Kritchman Lupo, Shalvata Mental Health Center.
Recruitment status was: Recruiting
First Posted : February 25, 2013
Last Update Posted : March 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Methylphenidate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind Randomized Crossover Study of the Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||May 2016|
Active Comparator: Methylphenidate
Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test.
Placebo Comparator: Placebo
Placebo is given before performing a continuous performance test.
- State anxiety [ Time Frame: 1 year ]State anxiety will be measured by the Spielberger's state anxiety inventory
- Cognitive function [ Time Frame: 1 year ]Cognitive function will be measured by the cambridge neuropsychological test automated battery
- Patient's perspective [ Time Frame: 1 year ]Patient's perspective will be measured by questionnaires assessing treatment adherence issues and patient's view regarding the use of placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798459
|Contact: Maya Kritchman-Lupo, MDfirstname.lastname@example.org; email@example.com|
|Contact: Yuval Bloch, MDfirstname.lastname@example.org|
|Contact: Maya Kritchman-Lupo, MD 972-9-7478644 email@example.com; firstname.lastname@example.org|
|Principal Investigator:||Maya Kritchman Lupo, MD||Shalvata Mental Health Center|