Conditions: Schizophrenia
Keywords: Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief summary:
This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) intervention 2: Placebo
Intervention descriptions: intervention 1: SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days. intervention 2: Placebo Capsule(s) for oral use taken once daily for 30 days

Protocol document: