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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Shalvata Mental Health Center
Sponsor:
Information provided by (Responsible Party):
Maya Kritchman Lupo, Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01798459
First received: February 18, 2013
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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 Intervention
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • State anxiety [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    State anxiety will be measured by the Spielberger's state anxiety inventory


Secondary Outcome Measures:
  • Cognitive function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Cognitive function will be measured by the cambridge neuropsychological test automated battery

  • Patient's perspective [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Patient's perspective will be measured by questionnaires assessing treatment adherence issues and patient's view regarding the use of placebo.


Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798459

Contacts
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
Israel
Shalvata Not yet 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
Principal Investigator: Maya Kritchman Lupo, MD Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Maya Kritchman Lupo, Resident, Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01798459     History of Changes
Other Study ID Numbers: 0009-12-SHA
Study First Received: February 18, 2013
Last Updated: February 21, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:
Attention Deficit Hyperactivity Disorder
Methylphenidate
Placebo
State anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Hyperkinesis
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014