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

Attention Deficit Hyperactivity Disorder Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01798459
• Other study ID #: 0009-12-SHA
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2013
• Last updated: March 20, 2015
• Start date: February 2013
• Est. completion date: May 2016

Study information

• Verified date: March 2015
• Source: Shalvata Mental Health Center
• Contact: Maya Kritchman-Lupo, MD
• Phone: 972-9-7478644
• Email: maiakr[@]clalit.org.il; mayakri[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Methylphenidate

Locations

Country	Name	City	State
Israel	Shalvata	Hod-hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State anxiety	State anxiety will be measured by the Spielberger's state anxiety inventory	1 year	No
Secondary	Cognitive function	Cognitive function will be measured by the cambridge neuropsychological test automated battery	1 year	No
Secondary	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	Yes