The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1
Capsule, dose titration, * 40 mg capsule once-daily for 1 week; then * 80 mg capsule once-daily for 4 weeks; then, * 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; * if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks
Capsule, dose titration, * 40 mg capsule once-daily for 1 week; then * 80 mg capsule once daily for 1 week; then * 120 mg capsule once-daily for 1 week, then, * 140 mg capsule once-daily for 2 weeks, then * 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; * if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Galiz Research
Miami Springs, Florida, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
St. Charles Psychiatric Associates
Saint Charles, Missouri, United States
CRI Lifetree
Philadelphia, Pennsylvania, United States
Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks
Time frame: Baseline and 26 weeks
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Time frame: Baseline and week 26
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Time frame: Up to 26 weeks
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One capsule a day for 26 weeks
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks
Time frame: Baseline and 26 weeks
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks
Time frame: Baseline and 26 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 26 weeks
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks
Time frame: Baseline and 26 weeks