The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.
Not required
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
SP Research PLLC/Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, United States
CRI Lifetree
Philadelphia, Pennsylvania, United States
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks
Time frame: Basline and 52 weeks
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks
Time frame: Baseline and 52 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 52 weeks
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks
Time frame: Baseline and 52 weeks
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks
Time frame: Baseline and 52 weeks
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks
Time frame: Baseline and 52 weeks
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks
Time frame: Baseline and 52 weeks
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks
Time frame: Baseline and 52 weeks
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks
Time frame: Baseline and 52 weeks
Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks
Time frame: Baseline and 52 weeks
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Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks
Time frame: Baseline and 52 weeks
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Time frame: Baseline and week 52
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Time frame: Up to 52 weeks
Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks
Time frame: Baseline and 52 weeks