Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)
Public ClinicalTrials.gov record NCT02618408. 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 (IA) in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 426 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
- NCT02618408
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 333 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
- Jan 25, 2016 (Actual)
- Primary completion
- Sep 4, 2019 (Actual)
- Completion
- Oct 24, 2019 (Actual)
- Last update posted
- Jan 2, 2024
2016 – 2019
United States locations
- U.S. sites
- 28
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| ProScience | Culver City | California | 90230 | — |
| Behavioral Research Specialists | Glendale | California | 91206 | — |
| Neuropsychiatric Research Center of Orange County | Orange | California | 92868 | — |
| Meridien Research at Florida Clinical Research Center | Bradenton | Florida | 34201 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Florida Clinical Research Center, LLC. | Maitland | Florida | 32751 | — |
| CNS Healthcare of Orlando | Orlando | Florida | 32801 | — |
| American Medical Research | Chicago | Illinois | 60617 | — |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | — |
| Psychiatric Associates | Overland Park | Kansas | 66211 | — |
| Hugo W Moser Research Institute at Kennedy Krieger | Baltimore | Maryland | 21205 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Ohio State University Nisonger Center Clinical Trials Program | Columbus | Ohio | 43210 | — |
| Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | — |
| Paradigm Research Professionals | Oklahoma City | Oklahoma | 73118 | — |
| Cyn3rgy Research | Gresham | Oregon | 97030 | — |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | 29407 | — |
| CNS Healthcare | Memphis | Tennessee | 38119 | — |
| Research Strategies of Memphis, LLC | Memphis | Tennessee | 38119 | — |
| Relaro Medical Trials | Dallas | Texas | 75243 | — |
| Bayou City Research Corporation | Houston | Texas | 77006 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| Road Runner Research | San Antonio | Texas | 78258 | — |
| Family Psychiatry of the Woodlands | The Woodlands | Texas | 77381 | — |
| Aspen Clinical Research | Orem | Utah | 84058 | — |
| Alliance Research Group, LLC. | Richmond | Virginia | 23230 | — |
| Seattle Children's Research Institute | Seattle | Washington | 98121 | — |
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 NCT02618408, 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 Jan 2, 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 NCT02618408 live on ClinicalTrials.gov.