Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)
NCT ID: NCT02618408
Last Updated: 2024-01-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
333 participants
INTERVENTIONAL
2016-01-25
2019-10-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
NCT02618434
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
NCT02691182
A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT01364662
Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
NCT03597503
Open-Label, Extension Study to 810P202
NCT01416064
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low dose SPN-810 (18 mg)
Oral
SPN-810 (18 mg)
Subjects were randomized to receive SPN-810 low dose (18 mg) twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.
High dose SPN-810 (36 mg)
Oral
SPN-810 (36 mg)
Subjects were randomized to receive SPN-810 high dose (36 mg) twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.
Placebo
Oral
Placebo
Subjects were randomized to receive Placebo twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPN-810 (18 mg)
Subjects were randomized to receive SPN-810 low dose (18 mg) twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.
SPN-810 (36 mg)
Subjects were randomized to receive SPN-810 high dose (36 mg) twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.
Placebo
Subjects were randomized to receive Placebo twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders- 5 (DSM-5 confirmed by the Schedule for Affective Disorders and Schizophrenia for School-aged Children - Present and Lifetime Version 2013 (K-SADS-PL 2013).
3. Retrospective Modified Overt Aggression Scale (R-MOAS) score of ≥24 at screening.
4. CGI-S score of at least moderately ill at both Screening and Randomization.
5. Vitiello Aggression Scale score from -2 to -5 at screening.
6. Free of antipsychotic medication for at least two weeks prior to Visit 2.
7. Monotherapy treatment with FDA-approved optimized ADHD medication (psychostimulant or non-stimulant) at an FDA-approved dose for at least one month prior to screening, and willing to maintain that dose throughout the Baseline and Treatment period.
8. α 2- adrenergic agonists (e.g., clonidine and guanfacine) used for any other reason except for monotherapy treatment for ADHD (e.g., aggression or insomnia) must be discontinued at least two weeks prior to Visit 2.
9. Medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
10. Weight of at least 20 kg.
11. Able and willing to swallow tablets whole and not chewed, cut, or crushed.
12. Written Informed Consent obtained from the subject's parent or legal representative and written Informed Assent obtained from the subject if appropriate.
13. Measurement of compliance ≥ 80% for completion of IA Diary during Baseline Period.
Exclusion Criteria
2. Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or a related disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
3. Currently meeting DSM-5 criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as the primary diagnosis.
4. Use of anticonvulsants including carbamazepine and valproic acid, antidepressants, mood stabilizers including lithium, benzodiazepines, cholinesterase inhibitors, or any drug known to inhibit CYP2D6 activity within two weeks of Visit 2.
5. Use of herbal supplements within one week of Visit 2.
6. Known or suspected intelligence quotient (IQ) \< 70.
7. Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.
8. Suicidality, defined as either active suicidal plan/intent or active suicidal thoughts in the six months before the Screening Visit or more than one-lifetime suicide attempt.
9. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential and sexually active males).
10. Substance or alcohol use during the last three months.
11. Urine drug test at screening that is positive for alcohol or drugs of abuse.
12. Known allergy or sensitivity to molindone hydrochloride.
13. Any reason which, in the opinion of the Investigator or the Sponsor, would prevent the subject and subject's caregiver from participating in the study or complying with the study procedures.
14. Use of an investigational drug or participation in an investigational study within 30 days prior to Visit 2.
6 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Azmi Nasser, PhD
Role: STUDY_DIRECTOR
Supernus Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Woodland Research Northwest
Rogers, Arkansas, United States
ProScience
Culver City, California, United States
Behavioral Research Specialists
Glendale, California, United States
Neuropsychiatric Research Center of Orange County
Orange, California, United States
Meridien Research at Florida Clinical Research Center
Bradenton, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Florida Clinical Research Center, LLC.
Maitland, Florida, United States
CNS Healthcare of Orlando
Orlando, Florida, United States
American Medical Research
Chicago, Illinois, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Psychiatric Associates
Overland Park, Kansas, United States
Hugo W Moser Research Institute at Kennedy Krieger
Baltimore, Maryland, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Ohio State University Nisonger Center Clinical Trials Program
Columbus, Ohio, United States
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, United States
Paradigm Research Professionals
Oklahoma City, Oklahoma, United States
Cyn3rgy Research
Gresham, Oregon, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States
CNS Healthcare
Memphis, Tennessee, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee, United States
Relaro Medical Trials
Dallas, Texas, United States
Bayou City Research Corporation
Houston, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Road Runner Research
San Antonio, Texas, United States
Family Psychiatry of the Woodlands
The Woodlands, Texas, United States
Aspen Clinical Research
Orem, Utah, United States
Alliance Research Group, LLC.
Richmond, Virginia, United States
Seattle Children's Research Institute
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
810P301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.