The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|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.|
- State anxiety [ Time Frame: 1 year ] [ Designated as safety issue: No ]State anxiety will be measured by the Spielberger's state anxiety inventory
- Cognitive function [ Time Frame: 1 year ] [ Designated as safety issue: No ]Cognitive function will be measured by the cambridge neuropsychological test automated battery
- Patient's perspective [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Patient's perspective will be measured by questionnaires assessing treatment adherence issues and patient's view regarding the use of placebo.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|