SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
- Conditions
- ADHD
- Interventions
- Drug: SPD503 (Guanfacine hydrochloride)Drug: Placebo
- Registration Number
- NCT00367835
- Lead Sponsor
- Shire
- Brief Summary
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
- Healthy subjects with ADHD and oppositional symptoms
- ADHD-RS>=24
- CGI >=4
- T-score of Opp subscale CPRS-R:L >=65
- Normal ECG and BP
- >= 55 lbs
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPD503 (Guanfacine hydrochloride) SPD503 (Guanfacine hydrochloride) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks Baseline and up to 8 weeks The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.
- Secondary Outcome Measures
Name Time Method Assessment of Clinical Global Impression-Severity of Illness (CGI-S) up to 8 weeks CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks Baseline and up to 8 weeks QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) up to 8 weeks CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks Baseline and up to 8 weeks The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents.
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks Baseline and up to 8 weeks The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks Baseline and up to 8 weeks Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity.
Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS) up to 8 weeks The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of "strongly agree" or "agree".
Change From Baseline in Pulse Rate at Up to 8 Weeks Baseline and up to 8 weeks Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks Baseline and up to 8 weeks Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks Baseline and up to 8 weeks
Trial Locations
- Locations (32)
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Valley Clinical Research
🇺🇸El Centro, California, United States
Peninsula Research Associates Inc
🇺🇸Rolling Hills Estates, California, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Amedica Research Institute, Inc
🇺🇸Hialeah, Florida, United States
CORE Research, Inc
🇺🇸Maitland, Florida, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Orlando, Florida, United States
Childrens Developmental Center
🇺🇸Winter Park, Florida, United States
Scroll for more (22 remaining)HOPE Research Institute🇺🇸Phoenix, Arizona, United States