NCT01798459

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 23, 2015

Status Verified

March 1, 2015

Enrollment Period

2.7 years

First QC Date

February 18, 2013

Last Update Submit

March 20, 2015

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity DisorderMethylphenidatePlaceboState anxiety

Outcome Measures

Primary Outcomes (1)

  • State anxiety

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

    1 year

Secondary Outcomes (2)

  • Cognitive function

    1 year

  • Patient's perspective

    1 year

Study Arms (2)

Methylphenidate

ACTIVE COMPARATOR

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

Drug: Methylphenidate

Placebo

PLACEBO COMPARATOR

Placebo is given before performing a continuous performance test.

Interventions

MethylphenidateDRUG
Methylphenidate

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Attention deficit and hyperactivity disorder
  • Children aged 8-18 years

You may not qualify if:

  • Pervasive developmental disorder
  • Schizophrenia
  • Bipolar disorder
  • Current depressive episode
  • Current Anxiety disorder
  • Drug use during the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata

Hod HaSharon, Israel

RECRUITING

Related Publications (3)

  • Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.

    PMID: 41342306DERIVED

  • Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.

    PMID: 36971690DERIVED

  • 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.

    PMID: 31156406DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAnxiety Disorders

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Maya Kritchman Lupo, MD

    Shalvata Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Kritchman-Lupo, MD

CONTACT

972-9-7478644maiakr@clalit.org.il; mayakri@gmail.com

Yuval Bloch, MD

CONTACT

972-9-7478510yuvalbl@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 25, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2015

Study Completion

May 1, 2016

Last Updated

March 23, 2015

Record last verified: 2015-03

Locations

IL(1)