Get in Touch
ERG’s mission is to provide the highest quality clinical trial execution across all clinical research phases to help sponsors.
St. Louis Clinical Trials
Stable Schizophrenia Phase 2a PSG Case Study
A Phase 2a, Multicenter, Randomized, Double-Blind, Active-Controlled Pilot Polysomnography Study of the Effects of XXXXX on Sleep in Adult Subjects with Stable Schizophrenia
Key Elements
- Complex Design
- PK, ECG, PSG, Actigraphy
35 days
Inpatient Period
10
Subjects
29
Vital per subject
Phase: 2a
Indication: Schizophrenia (Stable)
# of Subjects: 10
Inpatient Period: 35 days
Objectives
Primary
Examine the XXXXX sleep profile compared to aripiprazole as measured bypolysomnography
Secondary
Compare the XXXXX efficacy via:
- Positive and Negative Syndrome Scale
- Clinical Global Impression - Severity of Illness scale (CGI-S) and Clinical Global Impression – Improvement scale(CGI-I)
Lab Assessments - 16 per subject
Screening
Day 1, Day 14, Day 15, Day 21: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12and 24 hours, Day 28, Day 29
ECGs - 5 per subject
Day -7
Day 1
Day 14
Day 28
- Standard 12-lead ECGs performed after the subject hasbeen supine and at rest for ≥ 5 minutes
Vitals - 29 per subject
Daily
- Blood pressure and heart rate measured in supine,sitting, and standing positions after rest in eachposition for 3 mins
Computerized Cognition Testing
Day -1, Day -2, Day 1, Day 27, Day 28
Polysomnography
Day -8, Days -2 & -1, Days 6 & 7, Days 13 & 14, Days 27 & 28
Actigraphy
Continuous measurements from Day -2 thru Day 29
Ratings
Positive and Negative Syndrome Scale (PANSS)Clinical Global Impression Severity Scale (CGI-S)Clinical Global Impression Improvement Scale (CGI-I)Mini International Neuropsychiatric Interview (M.I.N.I.)Simpson Angus Scale (SAS)Abnormal Involuntary Movement Scale (AIMS)Barnes Akathisia Rating Scale (BARS)Columbia-Suicide Severity Rating Scale (C-SSRS)
