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?

<p>15-21 (B)</p> 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?

<p>To ensure protocol compliance (A)</p> Signup and view all the answers

What is the QIDS-SR-16 derived from?

<p>The 30-item Inventory of Depressive Symptomatology (IDS SR-30) (D)</p> Signup and view all the answers

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

<p>To screen for potential psychiatric symptoms (B)</p> Signup and view all the answers

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

<p>Pre-dose and post-dose (D)</p> Signup and view all the answers

What is the total range of scores for the CADSS?

<p>0-92 (D)</p> Signup and view all the answers

What is the purpose of the Digit Symbol Substitution Test?

<p>To evaluate cognitive dysfunction and changes in cognitive function (B)</p> Signup and view all the answers

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

<p>23 (D)</p> Signup and view all the answers

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

<p>To monitor and manage safety (D)</p> Signup and view all the answers

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

<p>To allow for the use of remaining samples in future research (A)</p> Signup and view all the answers

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

<p>Pre-dose only (D)</p> Signup and view all the answers

What is the purpose of the MOAA/S assessment?

<p>To measure treatment-emergent sedation (D)</p> Signup and view all the answers

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

<p>A 6-point scale (A)</p> Signup and view all the answers

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

<p>4 subscales (A)</p> Signup and view all the answers

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

<p>Pre-dose and post-dose (B)</p> Signup and view all the answers

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