Trial Outcomes & Findings for Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder (NCT NCT04170738)

Results Overview

Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

baseline and 3 weeks post intervention

Results posted on

2024-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	High Risk Children with ADHD and ODD/CD	Low Risk Children with ADHD only
Overall Study STARTED	26	7
Overall Study COMPLETED	11	7
Overall Study NOT COMPLETED	15	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Risk n=11 Participants Children with ADHD and ODD/CD	Low Risk n=7 Participants Children with ADHD only	Total n=18 Participants Total of all reporting groups
Age, Continuous	9.00 years STANDARD_DEVIATION 1.483 • n=11 Participants	10.14 years STANDARD_DEVIATION 1.345 • n=7 Participants	9.44 years STANDARD_DEVIATION 1.5 • n=18 Participants
Sex: Female, Male Female	4 Participants n=11 Participants	1 Participants n=7 Participants	5 Participants n=18 Participants
Sex: Female, Male Male	7 Participants n=11 Participants	6 Participants n=7 Participants	13 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Full Scale IQ (FSIQ)	102.45 units on a scale STANDARD_DEVIATION 12.003 • n=11 Participants	107.29 units on a scale STANDARD_DEVIATION 11.041 • n=7 Participants	104.9 units on a scale STANDARD_DEVIATION 11.5 • n=18 Participants

PRIMARY outcome

Timeframe: baseline and 3 weeks post intervention

Population: Participants who provided imaging data

Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).

Outcome measures

Outcome measures
Measure	High Risk n=7 Participants Children with ADHD and ODD/CD	Low Risk n=6 Participants Children with ADHD only
Change in fMRI Measure Reward Outcome Post-Pre Low>High, ACC	-0.139000 BOLD signal Standard Deviation 1.288470	1.876717 BOLD signal Standard Deviation 1.615755
Change in fMRI Measure Reward Outcome Post-Pre Low>High, Left Amygdala	-0.957100 BOLD signal Standard Deviation 1.365781	0.572517 BOLD signal Standard Deviation 0.712410
Change in fMRI Measure Reward Outcome Post-Pre Low>High, Ventral Striatum	0.853514 BOLD signal Standard Deviation 0.475767	-0.321983 BOLD signal Standard Deviation 1.075986504
Change in fMRI Measure Reward Outcome Post-Pre Low>High, Ventrolateral Pre-Frontal Cortex (VLPFC)	0.712514 BOLD signal Standard Deviation 0.944126	0.460432 BOLD signal Standard Deviation 0.744686

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Risk n=11 Participants Children with ADHD and ODD/CD	Low Risk n=7 Participants Children with ADHD only
ADHD Rating Score (ADHD RS) ADHRS-total baseline	43.18 score on a scale Standard Deviation 7.264	39.86 score on a scale Standard Deviation 13.057
ADHD Rating Score (ADHD RS) ADHRS-total post Tx	20.36 score on a scale Standard Deviation 13.677	12.71 score on a scale Standard Deviation 5.314
ADHD Rating Score (ADHD RS) ADHRS-hyper baseline	20.55 score on a scale Standard Deviation 5.298	19.71 score on a scale Standard Deviation 6.651
ADHD Rating Score (ADHD RS) ADHRS-hyper post Tx	10.09 score on a scale Standard Deviation 7.355	8.86 score on a scale Standard Deviation 3.805
ADHD Rating Score (ADHD RS) ADHRS-InAtt baseline	22.64 score on a scale Standard Deviation 3.906	20.14 score on a scale Standard Deviation 7.988
ADHD Rating Score (ADHD RS) ADHRS- InAtt post Tx	10.27 score on a scale Standard Deviation 7.016	8.86 score on a scale Standard Deviation 3.805

SECONDARY outcome

Timeframe: average 2 weeks

Open label trial of MAS XR with flexible dosing and a suggested target of at least 0.5mg/kg

Outcome measures

Outcome measures
Measure	High Risk n=11 Participants Children with ADHD and ODD/CD	Low Risk n=7 Participants Children with ADHD only
Total Dose of MAS-XR	1487.09 mg Standard Deviation 2108.303	745.00 mg Standard Deviation 594.636

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	High Risk n=11 Participants Children with ADHD and ODD/CD	Low Risk n=7 Participants Children with ADHD only
Change in Clinical Global Impression - Improvement (CGI-I)	2.0 score on a scale Standard Deviation 0.632	2.00 score on a scale Standard Deviation 0.577

Adverse Events

High Risk

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Risk

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Iliyan Ivanov

Icahn School of Medicine at Mount Sinai

Phone: (212) 523-1924

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place