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OT and Social Cognition in Children With ADHD: Impact of MPH

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ClinicalTrials.gov Identifier: NCT03788902
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yuval Bloch, Shalvata Mental Health Center

Brief Summary:
Background: The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide found to regulate social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Methods: In a double-blind manner the investigators compared the performance of 50 children with ADHD and 40 HCs in "theory of mind" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction.

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Oxytocin and Social Cognition in Children With Attention Deficit Hyperactivity Disorder: Impact of Methylphenidate
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : January 1, 2017


Arm Intervention/treatment
Experimental: ADHD group
This group was examined twice - once after taking Ritalin and once after taking placebo
Drug: Ritalin
Single dose of Ritalin IR 0.3-0.5 mg/kg OR placebo

No Intervention: Healthy control
Children with the same demographics as children with ADHD but without ADHD or a first degree relative with ADHD



Primary Outcome Measures :
  1. changes in scores of ToM test [ Time Frame: 20 minutes ]
    ToM test - consists of vignettes, stories, and drawings about which the child has to answer a number of questions.

  2. changes in scores of Faux-Pas Recognition test [ Time Frame: 15 minutes ]
    number of faux-pas recognized in specific vignettes by participants

  3. changes in Oxytocin salivary level [ Time Frame: 2 hours ]
    Oxytocin salivary levels as measured three/two times during the examination (ADHD group and healthy control accordingly).



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 6-12 years
  • Diagnosis of ADHD

Exclusion Criteria:

  • Past or current affective disorder, psychosis, substance abuse, conduct disorder
  • Any medical or neurological condition or medication-taking that might affect the child's participation in the study
  • First-degree relative with a major psychiatric diagnosis

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): NCT03788902


Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
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Principal Investigator: Hagai Maoz, MD Shalvata Mental Health Center

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Responsible Party: Yuval Bloch, Head of child and adolescent outpatient clinic, Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT03788902     History of Changes
Other Study ID Numbers: 0017-13-SHA
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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