Adults 7 to 12, any sex, with Attention Deficit Disorder With Hyperactivity or Conduct Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in fMRI MeasurePrimary· baseline and 3 weeks post intervention
Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).
ADHD Rating Score (ADHD RS)Secondary· Pretreatment, baseline and Post-Treatment, average 2 weeks
Subscale for Inattention scores range from 0-27, Subscale scores for Hyper (H/I) range from 0-27. The total ADHD score sums to a score of 0-54. Higher indicates more severe ADHD symptomology, and there are norm ranges, with clinical thresholds set at 1.5 SD above the mean for sex and age.
ADHRS-total baseline
Group
Value
95% CI
High Risk
43.18
± 7.264
Low Risk
39.86
± 13.057
ADHRS-total post Tx
Group
Value
95% CI
High Risk
20.36
± 13.677
Low Risk
12.71
± 5.314
ADHRS-hyper baseline
Group
Value
95% CI
High Risk
20.55
± 5.298
Low Risk
19.71
± 6.651
ADHRS-hyper post Tx
Group
Value
95% CI
High Risk
10.09
± 7.355
Low Risk
8.86
± 3.805
ADHRS-InAtt baseline
Group
Value
95% CI
High Risk
22.64
± 3.906
Low Risk
20.14
± 7.988
ADHRS- InAtt post Tx
Group
Value
95% CI
High Risk
10.27
± 7.016
Low Risk
8.86
± 3.805
Total Dose of MAS-XRSecondary· average 2 weeks
Open label trial of MAS XR with flexible dosing and a suggested target of at least 0.5mg/kg
Group
Value
95% CI
High Risk
1487.09
± 2108.303
Low Risk
745.00
± 594.636
Change in Clinical Global Impression - Improvement (CGI-I)Secondary· baseline and post treatment, average 2 weeks
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Change in CGi post treatment as compared to baseline.
Group
Value
95% CI
High Risk
2.0
± 0.632
Low Risk
2.00
± 0.577
Sponsor's own description
Childhood ADHD and comorbid oppositional defiant disorder (ODD) and conduct disorder (CD) are considered risk factors for subsequent substance abuse, and youth with both ADHD and ODD/CD are at greatest risk.
However, the effects of treatment of ADHD with stimulant medications such as methylphenidate (MPH) and mixed amphetamine salts (MAS) on risk for substance abuse are poorly understood. The study team propose to use fMRI to study the effects of extended release mixed amphetamine salts (MAS-XR) in drug-naïve youth 7-12 years at low risk (i.e., ADHD only) and high risk (i.e., ADHD + ODD/CD) for substance abuse on the brain reward system, to better understand the potential impact of these medications on an aspect of brain functioning which is thought to underlie vulnerability to substance abuse.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jeffrey Newcorn
Last refreshed: 29 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04170738.