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

NCT ID: NCT01798459

Last Updated: 2015-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methylphenidate

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

Group Type ACTIVE_COMPARATOR

Methylphenidate

Intervention Type DRUG

Placebo

Placebo is given before performing a continuous performance test.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Methylphenidate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Maya Kritchman Lupo

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maya Kritchman Lupo, MD

Role: PRINCIPAL_INVESTIGATOR

Shalvata Mental Health Center

Locations

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Shalvata

Hod HaSharon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Maya Kritchman-Lupo, MD

Role: CONTACT

Yuval Bloch, MD

Role: CONTACT

972-9-7478510

Facility Contacts

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Maya Kritchman-Lupo, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36971690 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31156406 (View on PubMed)

Other Identifiers

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0009-12-SHA

Identifier Type: -

Identifier Source: org_study_id

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