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MADRS Rater and PCRS Administration

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Questions and Answers

When will the PCRS be audio recorded during the study?

At each visit the MADRS is performed during the Double-blind treatment period (correct)

Only at the EOT/ET visit

At every visit, including the FU visit

Before the MADRS Rater administers the MADRS

What is the purpose of the Generalized Anxiety Disorder 7-item Scale?

To evaluate the effectiveness of the treatment

To measure the severity of depressive symptoms

To assess the severity of generalized anxiety disorder symptoms (correct)

To monitor the side effects of the treatment

When should the Generalized Anxiety Disorder 7-item Scale be administered during the on-site dosing visits?

Post-dose

Only at the EOT/ET visit

Pre-dose (correct)

At any time during the visit

What is the score range for severe anxiety in the Generalized Anxiety Disorder 7-item Scale?

15-21 Signup and view all the answers

What is the purpose of the MADRS Rater reading the PCRS before administering the MADRS at each study visit?

To ensure protocol compliance Signup and view all the answers

What is the QIDS-SR-16 derived from?

The 30-item Inventory of Depressive Symptomatology (IDS SR-30) Signup and view all the answers

What is the purpose of the Positive Symptoms subscale of the BPRS?

To screen for potential psychiatric symptoms Signup and view all the answers

When should the assessment of the Positive Symptoms subscale of the BPRS be conducted?

Pre-dose and post-dose Signup and view all the answers

What is the total range of scores for the CADSS?

0-92 Signup and view all the answers

What is the purpose of the Digit Symbol Substitution Test?

To evaluate cognitive dysfunction and changes in cognitive function Signup and view all the answers

How many items are in the Clinician-Administered Dissociative States Scale (CADSS)?

23 Signup and view all the answers

What is the primary purpose of the assessments in this clinical trial?

To monitor and manage safety Signup and view all the answers

What is the purpose of obtaining subjects' consent in this study?

To allow for the use of remaining samples in future research Signup and view all the answers

When should the C-SSRS assessment be conducted during on-site dosing visits?

Pre-dose only Signup and view all the answers

What is the purpose of the MOAA/S assessment?

To measure treatment-emergent sedation Signup and view all the answers

What is the scale used to measure alertness/sedation in the MOAA/S assessment?

A 6-point scale Signup and view all the answers

How many subscales are included in the 4-item BPRS assessment?

4 subscales Signup and view all the answers

When should the MOAA/S assessment be conducted during on-site dosing visits?