Status:
WITHDRAWN
SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia
Lead Sponsor:
Shire
Conditions:
Negative Symptoms of Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 27 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01234298
Start Date
January 27 2012
End Date
February 24 2014
Last Update
June 3 2021
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