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Midwest Clinical Research Center
Schizophrenia Phase 3 Case Study
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of XXX-XXXX (90 mg and 120 mg) as a Treatment in Subjects with Acute Schizophrenia Over 8 Weeks (2 Subcutaneous Doses)
Key Elements
- Long Confinement
15
Subjects
60 Days
Inpatient period
4
Lab assessments per subject
Phase: 3
Indication: Schizophrenia
# of Subjects: 15
Inpatient Period: 60 days
Objectives
PrimaryTo assess the efficacy of XXX-XXXX (90 mg and 120 mg) compared with placebo on the symptoms of schizophrenia over an 8-week treatment period using the change from baseline to end of treatment in the total Positive and Negative Syndrome Scale (PANSS) score, which is the sum of all 30 PANSS items.
Secondary
- To assess the efficacy of XXX-XXXX (90 mg and 120 mg doses) compared with placebo over an 8-weektreatment period using the change from baseline to end of treatment in the Clinical Global Impression –Severity of Illness (CGI-S) Scale.
- To establish a pharmacokinetic (PK)/pharmacodynamic(PD) model using non-linear mixed effectmodeling approach.
Ratings
Positive and Negative Syndrome Scale (PANSS)Clinical Global Impression Severity Scale (CGI-S)Abnormal Involuntary Movement Scale (AIMS)Barnes Akathisia Rating Scale (BARS)Columbia-Suicide Severity Rating Scale (C-SSRS)
Lab Assessments — 4 per subject: Screening, Day 1, Day 29, Day 57
ECGs—4 per subjectPrescreening
Day 1
Day 29
Day 57
- Standard 12-lead ECGs performed after the subjecthas been supine and at rest for ≥ 5 minutesVitals — 9 per subjectPrescreening, Day -1, Day 1, Day 2, Day 15, Day 29, Day 30, Day 43, Day 57
- Includes blood pressure, pulse, respiratory rate, and oral temperature after 5 minutes in the supine position.
