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

Not Applicable

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Methylphenidate

• Registration Number: NCT01798459
• Lead Sponsor: Shalvata Mental Health Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-20
• Last Update Posted: 2015-03-23
• Primary Completion: 2015-10
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Methylphenidate	Methylphenidate	Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test.

Primary Outcome Measures

Name	Time	Method
State anxiety	1 year	State anxiety will be measured by the Spielberger's state anxiety inventory

Secondary Outcome Measures

Name	Time	Method
Patient's perspective	1 year	Patient's perspective will be measured by questionnaires assessing treatment adherence issues and patient's view regarding the use of placebo.
Cognitive function	1 year	Cognitive function will be measured by the cambridge neuropsychological test automated battery

Trial Locations

Locations (1)

Shalvata; 🇮🇱 Hod-hasharon, Israel