SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia (NSS)

Shire

Status and phase: Withdrawn; Phase 3

Conditions: Negative Symptoms of Schizophrenia

Treatments: Drug: SPD489 High-Dose; Drug: Placebo; Drug: SPD489 Low-Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01234298

SPD489-320

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

SPD489 Low-Dose

Experimental group

Treatment:

Drug: SPD489 Low-Dose

SPD489 High-Dose

Experimental group

Treatment:

Drug: SPD489 High-Dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo