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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA046029-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adderall | Experimental | dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adderall | Drug | 3 weeks of Adderall |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in fMRI Measure | Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs). | baseline and 3 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD Rating Score (ADHD RS) | 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. | Pretreatment, baseline and Post-Treatment, average 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Newcorn, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Iliyan Ivanov, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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| ID | Title | Description |
|---|---|---|
| FG000 | High Risk | Children with ADHD and ODD/CD |
| FG001 | Low Risk | Children with ADHD only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Risk | Children with ADHD and ODD/CD |
| BG001 | Low Risk | Children with ADHD only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in fMRI Measure | Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs). | Participants who provided imaging data | Posted | Mean | Standard Deviation | BOLD signal | baseline and 3 weeks post intervention |
|
|
3 weeks
Adverse Events collected using parent report
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Risk | Children with ADHD and ODD/CD | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Iliyan Ivanov | Icahn School of Medicine at Mount Sinai | (212) 523-1924 | iliyan.ivanov@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2023 | Aug 7, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 8, 2022 | Aug 7, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D019955 | Conduct Disorder |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C090411 | Adderall |
| C449521 | SLI381 |
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3-week intervention with Adderall as treatment for ADHD among youth with ADHD + Conduct problems. Pre and post fMRI performed as the outcome measures
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| Total Dose of MAS-XR | Open label trial of MAS XR with flexible dosing and a suggested target of at least 0.5mg/kg | average 2 weeks |
| Change in Clinical Global Impression - Improvement (CGI-I) | 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. | baseline and post treatment, average 2 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Full Scale IQ (FSIQ) | Full range from 40-160, higher score indicating better intellectual functioning | Mean | Standard Deviation | units on a scale |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | ADHD Rating Score (ADHD RS) | 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. | Posted | Mean | Standard Deviation | score on a scale | Pretreatment, baseline and Post-Treatment, average 2 weeks |
|
|
|
| Secondary | Total Dose of MAS-XR | Open label trial of MAS XR with flexible dosing and a suggested target of at least 0.5mg/kg | Posted | Mean | Standard Deviation | mg | average 2 weeks |
|
|
|
| Secondary | Change in Clinical Global Impression - Improvement (CGI-I) | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline and post treatment, average 2 weeks |
|
|
|
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Low Risk | Children with ADHD only | 0 | 7 | 0 | 7 | 0 | 7 |
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| ADHRS-hyper baseline |
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| ADHRS-hyper post Tx |
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| ADHRS-InAtt baseline |
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| ADHRS- InAtt post Tx |
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