Attention Deficit Disorder With Hyperactivity (ADHD)
Conditions
Keywords
ADHD, Attention Deficit Disorder with Hyperactivity
Brief summary
The purpose of this study is to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with placebo tablets.
Interventions
DRUGALKS 7290
ALKS 7290 tablets taken daily, orally, for 4 weeks
DRUGPlacebo
Placebo capsule taken daily
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meets the Diagnostic and Statistical Manual of Mental Disorders -5 criteria for ADHD, as confirmed by the Mini-International Neuropsychiatric Interview (MINI) for ADHD Studies 7.0.2. * Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants must be stable on permitted medication for 2 months prior to first visit, without anticipated changes to dose. * AISRS total score of ≥26 * CGI-S score ≥ 4 (moderately ill or worse) * Has a Body Mass Index within 18 to 35 kg/m2
Exclusion criteria
* Has a known history of intellectual developmental disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with study participation. * Has any of the following psychiatric conditions per the DSM-5 criteria, as assessed by the MINI. Conditions not assessable by the MINI should be assessed by clinical judgement; Diagnosis of schizophrenia, schizoaffective disorder, or bipolar I or II disorder, or current, unstable, MDD or GAD. * Clinically significant cognitive difficulties including dementia, delirium or amnestic syndromes, or any other cognitive disorder present with the past 2 years that could interfere with participation in the study. * Moderate to severe substance use disorder according to DSM-5 guidelines, including use of alcohol, nicotine, cannabis, narcotics, or any illicit substance. * Any other psychiatric condition that could interfere with participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score | Baseline to Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to Week 4 in Clinical Global Impression- Severity (CGI-S) scale score | Baseline to Week 4 |
| Incidence of treatment-emergent adverse events | Up to 6 weeks |
Countries
United States
Contacts
CONTACTGlobal Clinical Services
STUDY_DIRECTORMedical Director, MD
Alkermes, Inc.
Outcome results
None listed