SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia
Phase 3
Withdrawn
- Conditions
- Negative Symptoms of Schizophrenia
- Interventions
- Drug: SPD489 High-DoseDrug: PlaceboDrug: SPD489 Low-Dose
- Registration Number
- NCT01234298
- Lead Sponsor
- Shire
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPD489 High-Dose SPD489 High-Dose - Placebo Placebo - SPD489 Low-Dose SPD489 Low-Dose -
- Primary Outcome Measures
Name Time Method Negative Symptom Assessment (NSA-16) total score up to 26 weeks
- Secondary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale (PANSS) up to 26 weeks