Negative Symptoms of Schizophrenia Clinical Trial
— NSSOfficial 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
Verified date | May 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 24, 2014 |
Est. primary completion date | February 24, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Shire |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Negative Symptom Assessment (NSA-16) total score | up to 26 weeks | ||
Secondary | Positive and Negative Syndrome Scale (PANSS) | up to 26 weeks |
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