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St. Louis Clinical Trials
Acute Schizophrenia Phase 2 Case Study
A Phase 2 Six Week, Multicenter, Randomized Double-Blind Placebo Controlled Study to Evaluate Efficacy Safety and Tolerability Of Oral XXXXX Once Daily and Aripirizole Once Daily for Treatment of Hospitalized Adult Patients with Acute Schizophrenia
Key Elements
- Inpatient
- Long Confinement
10
Subjects
6 Week
Inpatient period
Phase: 2
Indication: Schizophrenia (Acute)
# of Subjects: 10
Inpatient Period: 6 weeks
Objectives
Primary
Change in PANSS Total Score
Secondary
Comparison of treatment group vs. placebo
- CGI-S and CGI-I scores
- PANSS positive subscale score
- PANSS negative subscale score
- Response rate
- PSP score
Ratings
Positive and Negative Syndrome Scale (PANSS)
Clinical Global Impression-Severity (CGI-S)
Clinical Global Impression-Improvement (CGI-I)
Personal and Social Performance Scale (PSP)
Simpson-Angus Scale (SAS)
Abnormal Involuntary Movement Scale (AIMS)
Barnes Akathisia Rating Scale (BARS)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Lab Assessments
Screening
Day 1: 0.5, 3, 10, and 20 hr post-dose
Week 3: 0.5, 3, 10, and 20 hr post-dose ECGs
Weekly
Standard 12-lead ECGs performed supine and at restfor ≥ 5 minutes prior to the ECG.
Vitals
WeeklyBlood pressure and heart rate measured in thesupine, sitting, and standing positions after thesubject has been in each position for at least 3minutes.
