1
Participants
Start Date
February 1, 2013
Primary Completion Date
April 1, 2013
Study Completion Date
April 1, 2013
SPD489 low dose range (40mg, 80mg, and 100mg)
"Capsule, dose titration,~* 40 mg capsule once-daily for 1 week; then~* 80 mg capsule once-daily for 4 weeks; then,~* 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~* if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
SPD489 high dose range (120mg, 140mg and 160mg)
"Capsule, dose titration,~* 40 mg capsule once-daily for 1 week; then~* 80 mg capsule once daily for 1 week; then~* 120 mg capsule once-daily for 1 week, then,~* 140 mg capsule once-daily for 2 weeks, then~* 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~* if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
Placebo
One capsule a day for 26 weeks
CRI Lifetree, Philadelphia
Galiz Research, Miami Springs
St. Charles Psychiatric Associates, Saint Charles
Psychiatric Care and Research Center, O'Fallon
Lead Sponsor
Shire
INDUSTRY