The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.

Study Overview
=================
Brief Summary
-----------------
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.

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.

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attention deficit and hyperactivity disorder Children aged 8-18 years Exclusion Criteria: Pervasive developmental disorder Schizophrenia Bipolar disorder Current depressive episode Current Anxiety disorder Drug use during the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylphenidate<br>Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test. | Drug: Methylphenidate<br> <br> |
| Placebo Comparator: Placebo<br>Placebo is given before performing a continuous performance test. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State anxiety | State anxiety will be measured by the Spielberger's state anxiety inventory | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Attention Deficit Hyperactivity Disorder, Methylphenidate, Placebo, State anxiety