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

March 20, 2015 updated by: Maya Kritchman Lupo, Shalvata Mental Health Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methylphenidate
Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test.
Drug: Methylphenidate
Placebo Comparator: Placebo
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
Time Frame: 1 year
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
Time Frame: 1 year
Cognitive function will be measured by the cambridge neuropsychological test automated battery
1 year
Patient's perspective
Time Frame: 1 year
Patient's perspective will be measured by questionnaires assessing treatment adherence issues and patient's view regarding the use of placebo.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shalvata Mental Health Center

Investigators

  • Principal Investigator: Maya Kritchman Lupo, MD, Shalvata Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0009-12-SHA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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