SCHIZOPHRENIA
This is the typical age of onset for schizophrenia.
What is late teens through early 30s.
This number is the highest PANSS score allowed into the study.
What is 120.
When is the MINI 7.02 administered?
What is Screening.
Describes when an SIV can be conducted and how a site can be activated.
What is SOP 1073 - Site Initiation and Site Activation
What is the primary endpoint?
The change from Baseline to Week 5 in PANSS total score.
Delusions and hallucinations are examples of this type of schizophrenia symptoms?
What are positive symptoms?
Fill in the blank for this exclusion criteria:
Participant has taken a depot antipsychotic within _____ cycles before Baseline.
1.5 cycles
When is the waist circumference measured?
Screening, BL and Day 35
This needs to be completed by all attendees at the Site Initiation Visit.
What is Form-1045 - 'Site Initiation Visit Attendance Log'.
These are the 2 target treatment groups:
What is 210/3mg BID and 330/6mg QD.
What approximate percentage of people have schizophrenia?
What is 1%
What is the timeframe for the current onset of exacerbation of symptoms allowed for the study?
2 month
Randomization
What is Day 1.
This person notifies Supply Chain when study drug can be shipped to the sites.
Who is the CTM.
This is the AE/SAE reporting period:
What is 'from the time of documented informed consent until the end of the study follow-up visit.'
Where does the term 'schizophrenia' come from?
phrenia = of the mind
Fill in the blank for this exclusion criteria:
Participant has ____% improvement in PANSS total score between the Screening and Baseline visits.
20%
What visits is the PANSS administered?
SCR, BL, D7, D14, D21, D28, D35
What are medical/pharmacy records.
These are the 3 dosing strengths:
What are 105/1.5mg, 105/3mg and 165/3mg.
This medication is considered the most effective antipsychotic, but it's use is limited by serious side effects.
Clozapine
This is the age range for eligibility.
Between ≥18 years and ≤64
Optional PK testing
When is Day 28 and Day 29.
This can occur once the essential documents package is complete and site is ready to start screening.
What is 'Site Activation'.
How do you spell Andy's last name?
Czysz