SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia

To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.

Inclusion Criteria:

• Subject has diagnosis of schizophrenia for at least 2 years
• Subject has persistent predominant negative symptoms
• Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
• Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
• Subject has been clinically stable and is in the non-acute phase of illness

Exclusion Criteria:

• Subject has clinically notable positive symptoms
• Subject is considered to be treatment refractory
• Subject has current history of substance abuse/dependance
• Subject is considered a suicide risk or risk to harm others