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Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents

NCT03333668 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-08-17

No results posted yet for this study

Summary

This is not a clinical trial. The aim of this study is to understand the mechanism of action of two recently licensed drugs for ADHD on brain function. We will compare the brain activation changes elicited by Guanfacine extended release (GXR; a non-stimulant drug) with the brain activation changes elicited by Lisdexamfetamine (LISDEX; a stimulant drug) and by placebo in 20 drug-free patients with ADHD using functional Magnetic Resonance Imaging (fMRI). For this purpose we intend to scan participants during their performance of tasks of attention, working memory, and inhibition, which we know from previous studies to elicit abnormal brain activation patterns in ADHD patients (Rubia et al., 2005; Smith et al., 2006).

Conditions

  • ADHD

Interventions

DRUG

Lisdexamfetamine dimesylate

Lisdexamfetamine dimesylate (30mg for smaller, 50mg for larger boys) tablet

DRUG

Guanfacine Extended Release Oral Tablet

Guanfacine Extended Release (0.05mg/kg) tablet

DRUG

Placebo

Vitamin C (10mg) tablet

Sponsors & Collaborators

Principal Investigators

  • Katya Rubia, PhD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2022-12-31
Completion
2025-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333668 on ClinicalTrials.gov