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

NCT03788902 | Completed

• 1 other identifier: 0017-13-SHA
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

• changes in scores of ToM test

  ToM test - consists of vignettes, stories, and drawings about which the child has to answer a number of questions.

  20 minutes

• changes in scores of Faux-Pas Recognition test

  number of faux-pas recognized in specific vignettes by participants

  15 minutes

• changes in Oxytocin salivary level

  Oxytocin salivary levels as measured three/two times during the examination (ADHD group and healthy control accordingly).

  2 hours

Study Arms (2)

ADHD group

EXPERIMENTAL

This group was examined twice - once after taking Ritalin and once after taking placebo

Drug: Ritalin

Healthy control

NO INTERVENTION

Children with the same demographics as children with ADHD but without ADHD or a first degree relative with ADHD

Interventions

Ritalin DRUG

Single dose of Ritalin IR 0.3-0.5 mg/kg OR placebo

ADHD group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ages 6-12 years
• Diagnosis of ADHD

You may not qualify if:

• 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

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hagai Maoz, MD

  Shalvata Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of child and adolescent outpatient clinic

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 28, 2018
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: December 28, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share