SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

Shire

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Negative Symptoms of Schizophrenia

Interventions

SPD489 Low-DoseDRUG

SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks

SPD489 High-DoseDRUG

SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks

PlaceboDRUG

Placebo capsule taken once-daily for up to 26 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Negative Symptom Assessment (NSA-16) total score

Time frame: up to 26 weeks

Secondary Outcomes

Positive and Negative Syndrome Scale (PANSS)

Time frame: up to 26 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.