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Clinical Trials/NCT01862484
NCT01862484
Completed
Not Applicable

Neuroimaging of Diet and Medication in the Treatment of ADHD

The University of Texas Health Science Center at San Antonio1 site in 1 country40 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit Disorder With Hyperactivity
Sponsor
The University of Texas Health Science Center at San Antonio
Enrollment
40
Locations
1
Primary Endpoint
ADHD Rating Scale IV
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be placed on a restriction diet for a 5 week period. Children will be randomized to either receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a double blind fashion. It is hypothesized that children who are consistently on the restricted diet (relative to those on the ruse diet) will show improvements in ADHD symptoms.

Detailed Description

The ADHD rating scale (RS) will be the principal behavioral outcome measure. We hypothesize that children on restriction diet will have significantly lower ADHD RS scores after 5 weeks relative to the Ruse diet group. In addition children will undergo functional magnetic resonance imaging (fMRI) at baseline and again at 5 weeks. Children will perform a flanker task known to engage the dorsolateral prefrontal cortex (DLPFC) and the anterior cingulate cortex (ACC) during attention tasks. The children will also perform will look at pictures of appealing and unappealing food and rate whether they would like to eat it or not. This task is known to activate the ventral striatum (VS) (reward processing). A secondary hypothesis is whether children on the restricted diet will show changes in activity and connectivity of areas (DLPFC, ACC, VS) relative to those on the Ruse diet.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven Pliszka

Professor and Chief, Division of Child and Adolescent Psychiatry

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

Inclusion Criteria

  • Age 9-12 years
  • Meets criteria for Attention Deficit Hyperactivity Disorder
  • Parent must agree to use Study Diet Manual

Exclusion Criteria

  • Any Axis I psychiatric disorder other than Oppositional Defiant Disorder or Anxiety Disorder not requiring psychopharmacological management
  • Not currently on any pharmacological agent other than medication for ADHD

Outcomes

Primary Outcomes

ADHD Rating Scale IV

Time Frame: 5 weeks

The ADHD Rating Scale is an 18 items scale containing items related to the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). It is filled out by the parent. Each item is rated 0-3, the range of scores is 0 to 54, with 25 being the score below which the patient is considered to be in remission. Reference: DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scales-IV: Checklists, Norms and Clinical Interpretation. New York, Guilford Press; 1998.

Study Sites (1)

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