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

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ClinicalTrials.gov Identifier: NCT01798459
Recruitment Status : Unknown
Verified March 2015 by Maya Kritchman Lupo, Shalvata Mental Health Center.
Recruitment status was:  Recruiting
First Posted : February 25, 2013
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Maya Kritchman Lupo, Shalvata Mental Health Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Methylphenidate Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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.
Study Start Date : February 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. State anxiety [ Time Frame: 1 year ]
    State anxiety will be measured by the Spielberger's state anxiety inventory


Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: 1 year ]
    Cognitive function will be measured by the cambridge neuropsychological test automated battery

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798459


Contacts
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Contact: Maya Kritchman-Lupo, MD 972-9-7478644 maiakr@clalit.org.il; mayakri@gmail.com
Contact: Yuval Bloch, MD 972-9-7478510 yuvalbl@clalit.org.il

Locations
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Israel
Shalvata Recruiting
Hod-hasharon, Israel
Contact: Maya Kritchman-Lupo, MD    972-9-7478644    maiakr@clalit.org.il; mayakri@gmail.com   
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
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Principal Investigator: Maya Kritchman Lupo, MD Shalvata Mental Health Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maya Kritchman Lupo, Resident, Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01798459    
Other Study ID Numbers: 0009-12-SHA
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015
Keywords provided by Maya Kritchman Lupo, Shalvata Mental Health Center:
Attention Deficit Hyperactivity Disorder
Methylphenidate
Placebo
State anxiety
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
 Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents