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| ID | Type | Description | Link |
|---|---|---|---|
| DSIR 84-CTM |
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| Name | Class |
|---|---|
| University of Texas | OTHER |
| Northwell Health | OTHER |
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This study will determine the advantages and disadvantages of adding one of two different types of drugs to stimulant treatment for reducing aggressive behavior in children with attention deficit with hyperactivity disorder (ADHD).
Attention deficit with hyperactivity disorder (ADHD) is a common childhood mental disorder that affects 3% to 5% of all American children. Symptoms of ADHD commonly include inability to focus or exercise normal inhibition, and in some cases, aggressive behavior. Approximately 33% to 50% of children with ADHD develop oppositional defiant disorder (ODD), and about 20% to 40% develop a conduct disorder (CD). These disorders are characterized by defiant, belligerent, and otherwise aggressive behavior. Treatment for ADHD generally includes use of stimulant medications that decrease impulsivity and increase attentiveness, such as methylphenidate (Ritalin) or dextroamphetamine (Dexedrine), but these do not always affect aggression. To treat aggression in ADHD, many physicians prescribe additional medications, including the mood stabilizing medication valproate and the antipsychotic medication risperidone.
There is no clinical evidence proving that using multiple types of medications is safe and effective. This study will treat children with ADHD and aggression with a combination of stimulants and antipsychotic or mood stabilizing medications to determine whether the aggressive behaviors and ADHD symptoms are reduced without harmful side effects.
This study has two phases. During the first phase, which will last 3 to 6 weeks, participants will be treated with normal ADHD stimulant medications. During the second phase, those whose aggressive behavior is not effectively suppressed by stimulant medication alone will then be randomly assigned to also receive valproate, risperidone, or placebo for 8 weeks. After 8 weeks, children whose aggression persists will be switched from either valproate to risperidone or risperidone to valproate for another 8 weeks. Those on placebo will not switch medications. All participants will attend weekly monitoring visits for 11 to 16 weeks over the course of the study. At these visits, aggression levels and medication side effects will be assessed. Families will also meet with the researchers to discuss the child's progress and will attend behavioral counseling with a therapist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | During Phase 1, participants will receive a stimulant medication. If they do not respond to the stimulant, they will add valproate and behavioral family counseling to their treatment during Phase 2. If they do not respond to valproate, they will be switched to risperidone. |
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| 2 | Experimental | During Phase 1, participants will receive a stimulant medication. If they do not respond to the stimulant, they will add risperidone and behavioral family counseling to their treatment during Phase 2. If they do not respond to risperidone, they will switch to valproate. |
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| 3 | Placebo Comparator | During Phase 1, participants will receive a stimulant medication. If they do not respond to the stimulant, they will add placebo and behavioral family counseling to their treatment during Phase 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproate | Drug | Standard therapeutic doses of valproate, set according to valproic acid blood level, for 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Aggressive behavior | Measured weekly for 11 to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD symptoms | Measured weekly for 11 to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph C. Blader, PhD, MSc | Contact | 631-632-8317 | joseph.blader@stonybrook.edu | |
| Lauren M. Chorney, PhD | Contact | 631-632-8317 | lauren.chorney@stonybrook.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joseph C. Blader, PhD, MSc | Stony Brook University School of Medicine, State University of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore - LIJ Health System, Zucker Hillside Hospital | Recruiting | Glen Oaks | New York | 11040 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32007604 | Derived | Blader JC, Pliszka SR, Kafantaris V, Foley CA, Carlson GA, Crowell JA, Bailey BY, Sauder C, Daviss WB, Sinha C, Matthews TL, Margulies DM. Stepped Treatment for Attention-Deficit/Hyperactivity Disorder and Aggressive Behavior: A Randomized, Controlled Trial of Adjunctive Risperidone, Divalproex Sodium, or Placebo After Stimulant Medication Optimization. J Am Acad Child Adolesc Psychiatry. 2021 Feb;60(2):236-251. doi: 10.1016/j.jaac.2019.12.009. Epub 2020 Jan 30. | |
| 26745211 |
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| Risperidone | Drug | Standard therapeutic doses of risperidone for 8 weeks |
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| Placebo | Drug | An inactive substance at identical dosing to active treatments for 8 weeks |
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| Stimulant medication | Drug | Stimulant medication standard in the care of ADHD, such as methylphenidate or dextroamphetamine |
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| Behavioral family counseling | Behavioral | Weekly behavioral counseling with a therapist |
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| Stony Brook University Medical Center | Recruiting | Stony Brook | New York | 11794-8790 | United States |
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| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| Blader JC, Pliszka SR, Kafantaris V, Sauder C, Posner J, Foley CA, Carlson GA, Crowell JA, Margulies DM. Prevalence and Treatment Outcomes of Persistent Negative Mood Among Children with Attention-Deficit/Hyperactivity Disorder and Aggressive Behavior. J Child Adolesc Psychopharmacol. 2016 Mar;26(2):164-73. doi: 10.1089/cap.2015.0112. Epub 2016 Jan 8. |
| 24290461 | Derived | Blader JC, Pliszka SR, Kafantaris V, Foley CA, Crowell JA, Carlson GA, Sauder CL, Margulies DM, Sinha C, Sverd J, Matthews TL, Bailey BY, Daviss WB. Callous-unemotional traits, proactive aggression, and treatment outcomes of aggressive children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2013 Dec;52(12):1281-93. doi: 10.1016/j.jaac.2013.08.024. Epub 2013 Sep 25. |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000374 | Aggression |
| D000096865 | Oppositional Defiant Disorder |
| D019955 | Conduct Disorder |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| D018967 | Risperidone |
| D000073893 | Sugars |
| D008774 | Methylphenidate |
| D003913 | Dextroamphetamine |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D010880 | Piperidines |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
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