Conditions: Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: SPD489 low dose range (40mg, 80mg, and 100mg) intervention 2: SPD489 high dose range (120mg, 140mg and 160mg) intervention 3: Placebo
Intervention descriptions: intervention 1: 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 intervention 2: 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 intervention 3: One capsule a day for 26 weeks

Protocol document: