A Double Blind Randomized Crossover Study of the Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.
Overview
- Phase
- Not Applicable
- Intervention
- Methylphenidate
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Shalvata Mental Health Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- State anxiety
- Last Updated
- 11 years ago
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.
Investigators
Maya Kritchman Lupo
Resident
Shalvata Mental Health Center
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
Arms & Interventions
Methylphenidate
Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test.
Intervention: Methylphenidate
Outcomes
Primary Outcomes
State anxiety
Time Frame: 1 year
State anxiety will be measured by the Spielberger's state anxiety inventory
Secondary Outcomes
- Patient's perspective(1 year)
- Cognitive function(1 year)