The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
Oral administration of 40 mg once-daily for up to 12 weeks
Oral administration of 100 mg once-daily for up to 12 weeks
Oral administration of 160 mg once-daily for up to 12 weeks
University Hills Clinical Research
Irving, Texas, United States
Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks
Time frame: Baseline and 12 weeks
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Oral administration once-daily for 12 weeks
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Time frame: Baseline and week 12
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Time frame: Up to 12 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 12 weeks
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks
Time frame: Baseline and 12 weeks
Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: Baseline and Weeks 4 and 10