SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

• Status: Withdrawn
• Trial end date: 2014-02-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Lisdexamfetamine Dimesylate

Criteria

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