search
Back to results

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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Methylphenidate
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Methylphenidate, Placebo, State anxiety

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ShalvataRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylphenidate

Placebo

Arm Description

Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test.

Placebo is given before performing a continuous performance test.

Outcomes

Primary Outcome Measures

State anxiety
State anxiety will be measured by the Spielberger's state anxiety inventory

Secondary Outcome Measures

Cognitive function
Cognitive function will be measured by the cambridge neuropsychological test automated battery
Patient's perspective
Patient's perspective will be measured by questionnaires assessing treatment adherence issues and patient's view regarding the use of placebo.

Full Information

First Posted
February 18, 2013
Last Updated
March 20, 2015
Sponsor
Shalvata Mental Health Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01798459
Brief Title
The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shalvata Mental Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, Methylphenidate, Placebo, State anxiety

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate
Arm Type
Active Comparator
Arm Description
Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is given before performing a continuous performance test.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Primary Outcome Measure Information:
Title
State anxiety
Description
State anxiety will be measured by the Spielberger's state anxiety inventory
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cognitive function
Description
Cognitive function will be measured by the cambridge neuropsychological test automated battery
Time Frame
1 year
Title
Patient's perspective
Description
Patient's perspective will be measured by questionnaires assessing treatment adherence issues and patient's view regarding the use of placebo.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Kritchman-Lupo, MD
Phone
972-9-7478644
Email
maiakr@clalit.org.il; mayakri@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Bloch, MD
Phone
972-9-7478510
Email
yuvalbl@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Kritchman Lupo, MD
Organizational Affiliation
Shalvata Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata
City
Hod-hasharon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Kritchman-Lupo, MD
Phone
972-9-7478644
Email
maiakr@clalit.org.il; mayakri@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31156406
Citation
Kritchman M, Koubi M, Mimouni Bloch A, Bloch Y. Effect of Methylphenidate on State Anxiety in Children With ADHD-A Single Dose, Placebo Controlled, Crossover Study. Front Behav Neurosci. 2019 May 15;13:106. doi: 10.3389/fnbeh.2019.00106. eCollection 2019.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs