Table 2.
Schedule of activities and assessments.
| Study day and visit window | Screening period | Active period | Follow-up period | ||||||
|
|
Screeninga (days −14 to −1 [minimum of 7 days between screening and baseline CAINSb]) | Baseline (day 1) | Week 4 (day 28 ± 3 days) | Week 8 (day 56 ± 3 days) | Week 12 (day 84 ± 3 days) | Week 16/early termination (day 112 ± 3 days) | Week 20 (day 140 ± 3 days) | ||
| Study visit number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | ||
| Clinic visit | ✓c | ✓ |
|
✓ |
|
✓ |
|
||
| Remote visitd |
|
|
✓ |
|
✓ |
|
✓ | ||
| Informed consent | ✓ |
|
|
|
|
|
|
||
| Demographics | ✓ |
|
|
|
|
|
|
||
| Inclusion/exclusion criteria | ✓ | ✓ |
|
|
|
|
|
||
| Medical history | ✓ |
|
|
|
|
|
|
||
| Psychiatric history and DSM-5e diagnosis of schizophrenia | ✓ |
|
|
|
|
|
|
||
| Urine drug screenf | ✓ | ✓ |
|
✓ |
|
✓ |
|
||
| Urine pregnancy testg | ✓ | ✓ |
|
✓ |
|
✓ |
|
||
| Randomization |
|
✓ |
|
|
|
|
|
||
| Download app and confirm understandingh | ✓ | ✓ |
|
|
|
|
|
||
| Complete enrollment in CT-155 study app to activate the assigned intervention |
|
✓ |
|
|
|
|
|
||
| Concomitant therapy | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Clinician-reported outcomes | |||||||||
|
|
CAINSi | ✓ | ✓ |
|
✓ |
|
✓ |
|
|
|
|
PANSSj | ✓ | ✓ |
|
✓ |
|
✓ |
|
|
|
|
CGI-Sk |
|
✓ |
|
✓ |
|
✓ |
|
|
|
|
PSPl |
|
✓ |
|
✓ |
|
✓ |
|
|
|
|
MINIm | ✓ |
|
|
|
|
|
|
|
|
|
C-SSRSn | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|
| Patient-reported outcomes | |||||||||
|
|
PGI-Io |
|
|
|
✓ |
|
✓ |
|
|
|
|
PGI-Sp |
|
✓ |
|
✓ |
|
✓ |
|
|
|
|
DASq |
|
✓ |
|
✓ |
|
✓ |
|
|
|
|
EQ-5D-5L |
|
✓ |
|
✓ |
|
✓ |
|
|
|
|
Sheehan Disability Scale (SDS) |
|
✓ |
|
✓ |
|
✓ |
|
|
|
|
WHODAS 2.0r |
|
✓ |
|
✓ |
|
✓ |
|
|
|
|
SQLS-R4s |
|
✓ |
|
✓ |
|
✓ |
|
|
| Adherence check (use of study app) |
|
|
✓ | ✓ | ✓ |
|
|
||
| Uninstall study app |
|
|
|
|
|
|
✓ | ||
aThe screening period was a minimum of 7 days before the baseline visit to allow for proper CAINS assessments.
bCAINS: Clinical Assessment Interview for Negative Symptoms.
cCheck marks show the activities and assessments that occurred at each study visit.
dAll remote visits were conducted via telephone. The Week 20 visit could be in-person if enrolling in NCT06067984, an open label extension study, the purpose of which was to evaluate the maintenance of effect as well as the safety of a second consecutive course of CT-155 [113].
eDSM-5: Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition).
fThe urine drug screen was conducted on-site.
gThe urine pregnancy test was conducted on-site using the dipstick method.
hThe study app could be installed at screening visit or baseline visit.
iCAINS was administered by a centralized blinded rater team, not the site clinician.
jPANSS: Positive and Negative Syndrome Scale.
kCGI-S: Clinical Global Impressions-Severity.
lPSP: Personal and Social Performance Scale.
mMINI: Mini International Neuropsychiatric Interview.
nC-SSRS: Columbia-Suicide Severity Rating Scale.
oPGI-I: Patient Global Impression of Improvement.
pPGI-S: Patient Global Impression of Severity.
qDAS: Dysfunctional Attitudes Scale.
rWHODAS 2.0: World Health Organization Disability Assessment Schedule.
sSQLS-R4: Schizophrenia Quality of Life Scale – Revision 4.