SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia
Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Negative Symptoms of Schizophrenia
Intervention: SPD489 Low-Dose (Drug); SPD489 High-Dose (Drug); Placebo (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Shire
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.
Clinical Details
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Negative Symptom Assessment (NSA-16) total score
Secondary outcome: Positive and Negative Syndrome Scale (PANSS)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: January 2012
Last updated: March 13, 2012
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