A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
323
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.
Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint
Time frame: (Week 16) or at time of discontinuation
Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S)
Time frame: at endpoint (Week 16)
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K & S Professional Research Services, Llc
Little Rock, Arkansas, United States
Comprehensive Neuroscience, Inc.
Cerritos, California, United States
Atp Clinical Research, Inc.
Costa Mesa, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
San Fernando Mental Health Center
Granada Hills, California, United States
Uci Medical Center
Orange, California, United States
California Clinical Trials Medical Group
Paramount, California, United States
California Clinical Trials
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
California Neuropsychopharmacology Clinical Research Inst.
San Diego, California, United States
...and 38 more locations