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

A Double Blind Randomized Crossover Study of the Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01798459

Enrollment

Registered

2013-02-25

Start date

2013-02-28

Completion date

2016-05-31

Last updated

2015-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder, Methylphenidate, Placebo, State anxiety

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.

Interventions

DRUGMethylphenidate

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
State anxiety	1 year	State anxiety will be measured by the Spielberger's state anxiety inventory

Secondary

Measure	Time frame	Description
Cognitive function	1 year	Cognitive function will be measured by the cambridge neuropsychological test automated battery
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.

Countries

Israel

Contacts

Primary ContactMaya Kritchman-Lupo, MD

maiakr@clalit.org.il; mayakri@gmail.com972-9-7478644

Backup ContactYuval Bloch, MD

yuvalbl@clalit.org.il972-9-7478510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026