Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Interventions
- Drug: placebo
- Registration Number
- NCT00640419
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- Have voluntarily signed an informed consent form.
- Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s).
- Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
- Subject weights at least 37 pounds (17 kg)
- Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
- Subject can swallow pills and subjects and parents are able to keep required appointments for clinic visits and all tests, including blood draws and examinations.
- Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger syndrome, pervasive developmental disorder, tics, Tourette syndrome, mental retardation, seizure disorder or traumatic brain injury.
- Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind.
- Subject has a history of, or ongoing, serious medical problem.
- Subject has a history of significant allergic reaction to any drug.
- Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
- Subject requires ongoing treatment with any psychiatric medication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ABT-089 - 2 ABT-089 - 3 placebo -
- Primary Outcome Measures
Name Time Method ADHD-RS-IV (HV) Screening, Day -1, Day 7, Day 14, Day 28, Day 42
- Secondary Outcome Measures
Name Time Method CSHQ Day-1, Day 28, Day 42 CGI-P Day -1, Day 21, Day 42 BRIEF Day -1, Day 28, Day 42 CGI-ADHD-S Screening, Day -1, Day 7, Day 14, Day 28 and Day 42
Related Research Topics
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Trial Locations
- Locations (13)
Site Reference ID/Investigator# 7536
🇺🇸Little Rock, Arkansas, United States
Site Reference ID/Investigator# 7954
🇺🇸Bradenton, Florida, United States
Site Reference ID/Investigator# 7543
🇺🇸Jacksonville, Florida, United States
Site Reference ID/Investigator# 7542
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 7537
🇺🇸Libertyville, Illinois, United States
Site Reference ID/Investigator# 7561
🇺🇸Overland Park, Kansas, United States
Site Reference ID/Investigator# 7560
🇺🇸Troy, Michigan, United States
Site Reference ID/Investigator# 7559
🇺🇸Omaha, Nebraska, United States
Site Reference ID/Investigator# 7541
🇺🇸Las Vegas, Nevada, United States
Site Reference ID/Investigator# 7564
🇺🇸Oklahoma City, Oklahoma, United States
Scroll for more (3 remaining)Site Reference ID/Investigator# 7536🇺🇸Little Rock, Arkansas, United States