Status:
UNKNOWN
Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents
Lead Sponsor:
King's College London
Collaborating Sponsors:
Shire
Conditions:
ADHD
Eligibility:
All Genders
8-20 years
Phase:
NA
Brief 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 eli...
Detailed Description
Twenty ADHD patients between 8 and 20 years of age will participate in the double-blind, randomised, active drug condition, within-group, placebo-controlled experimental fMRI study. Each participant w...
Eligibility Criteria
Inclusion
- Age range: 8-20 years
- Medication-naïve or non-medicated for two weeks or on stimulant medication, and willing to take the medication off for 48 hours before scans.
- Meeting DSM-5 diagnosis of ADHD
- Score above clinical cut-off on the ADHD module of the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) (Kaufman et al., 1997)
- Score above clinical cut-off for ADHD on the short forms of the Conners Parent Rating Scales, CPRS (Conners et al., 2008)
- Score above cut-off on the ADHD Rating Scale, ADHD-RS (DuPaul, et al., 1998)
- IQ \> 70 as tested on the WASI-II (Wechsler et al., 1999)
- Mood and depression symptoms will be allowed as long as they are not the primary diagnosis.
Exclusion
- IQ \< 70 (Wechsler et al., 1999).
- Comorbidity with schizophrenia, bipolar disorder, learning disability, OCD, severe depression with current suicidal behaviour (as assessed by a clinical interview)
- Neurological problems, i.e. a history of severe neurological illness, e.g. brain tumour, epilepsy or a history of symptomatic seizures, polyneuropathy etc.
- Substance abuse history
- Other illness (cardiovascular, renal, hepatic, metabolic) that would impact the data integrity or safety of the subject (i.e. contraindicated to any of the treatments) as determined by the investigators
- Contraindication to MRI. i.e., previous implantation of metallic material, pacemaker, implanted medication pumps, neural stimulators, claustrophobia
- Unable to give informed assent or consent in the case of the parent
- Contraindications for LISDEX and GXR use (i.e. advanced arteriosclerosis, agitated states, hyperexcitability, hyperthyroidism, moderate or severe hypertension, symptomatic cardiovascular disease)
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03333668
Start Date
October 1 2018
End Date
March 31 2025
Last Update
August 17 2022
Active Locations (1)
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1
Institute of Psychiatry, Psychology & Neuroscience; King's College London
London, United Kingdom, SE5 8AF