Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
Public ClinicalTrials.gov record NCT02618434. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Assessment of the Efficacy and Safety of Molindone Hydrochloride Extended-Release for the Treatment of Impulsive Aggression in Pediatric Patients With Attention Deficit/Hyperactivity Disorder in Conjunction With Standard ADHD Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 297 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.
Study identification
- NCT ID
- NCT02618434
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 297 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 6 Years to 12 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 16, 2016 (Actual)
- Primary completion
- Nov 15, 2019 (Actual)
- Completion
- Feb 14, 2020 (Actual)
- Last update posted
- Mar 18, 2024
2016 – 2020
United States locations
- U.S. sites
- 32
- U.S. states
- 20
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Metropolitan Neuro Behavioral Institute | Chandler | Arizona | 85226 | — |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | — |
| Sun Valley Research Center | Imperial | California | 92251 | — |
| Alliance for Wellness dba Alliance for Research | Long Beach | California | 90807 | — |
| ASCLEPES Research Center | Panorama City | California | 91402 | — |
| MCB Clinical Research Centers, LLC | Colorado Springs | Colorado | 80910 | — |
| Children's National Medical Center/Children's Research Institute | Washington D.C. | District of Columbia | 20310 | — |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | — |
| Indago Research & Health Center, Inc. | Hialeah | Florida | 33012 | — |
| Innovative Clinical Research, Inc | Lauderhill | Florida | 33319 | — |
| Laszlo J. Mate, M.D., P.A. | North Palm Beach | Florida | 71103 | — |
| APG Research, LLC | Orlando | Florida | 32803 | — |
| Miami Research Associates | South Miami | Florida | 33143 | — |
| University of South Florida- Dept. of Psychiatry and Neurosciences | Tampa | Florida | 33613 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| iResearch Atlanta | Decatur | Georgia | 30030 | — |
| Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| AMR Conventions Research | Naperville | Illinois | 60563 | — |
| Pedia Research | Evansville | Indiana | 47715 | — |
| Pedia Research | Owensboro | Kentucky | 42301 | — |
| Louisiana State University Health Sciences Center | Shreveport | Louisiana | 71103 | — |
| St. Charles Psychiatric Associates Midwest Research Center | Saint Charles | Missouri | 63304 | — |
| Alivation Research, LLC | Lincoln | Nebraska | 68526 | — |
| Quality Clinical Research | Omaha | Nebraska | 68114 | — |
| Hassmann Research Institute | Berlin | New Jersey | 08009 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| University of Cincinnati Department of Psychiatry and Behavioral Neuroscience | Cincinnati | Ohio | 45219 | — |
| BioBehavioral Research of Austin P.C. | Austin | Texas | 78759 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| Houston Clinical Trials | Houston | Texas | — | — |
| Ericksen Research & Development | Clinton | Utah | 84015 | — |
| Pacific Institute of Medical Sciences | Bothell | Washington | 98011 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02618434, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 18, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02618434 live on ClinicalTrials.gov.