MADRS Rater and PCRS Administration

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18 Questions

When will the PCRS be audio recorded during the study?

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

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

To assess the severity of generalized anxiety disorder symptoms

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

Pre-dose

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

15-21

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

To ensure protocol compliance

What is the QIDS-SR-16 derived from?

The 30-item Inventory of Depressive Symptomatology (IDS SR-30)

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

To screen for potential psychiatric symptoms

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

Pre-dose and post-dose

What is the total range of scores for the CADSS?

0-92

What is the purpose of the Digit Symbol Substitution Test?

To evaluate cognitive dysfunction and changes in cognitive function

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

23

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

To monitor and manage safety

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

To allow for the use of remaining samples in future research

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

Pre-dose only

What is the purpose of the MOAA/S assessment?

To measure treatment-emergent sedation

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

A 6-point scale

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

4 subscales

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

Pre-dose and post-dose

This quiz covers the administration of the MADRS Rater and PCRS at each study visit, including audio recording and assessment of the Generalized Anxiety Disorder 7-item Scale.

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