Medication Documentation

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What is the minimum washout period for medications like anticonvulsants, mood stabilizers, and psychostimulants before the first dose of study drug?

6 weeks

2 weeks

5 weeks

4 weeks (correct)

Why would a longer tapering/washout period be allowed for certain medications?

If the participant is under 18 years old

If the participant has a past history of depression

After discussion with the Medical Monitor (correct)

If the participant is taking more than two medications

What is not allowed within 4 weeks of the first dose of study drug?

Ketamine

Auvelity

All of the above (correct)

Ergometrine

During which period are ergometrine and xanthine-derivative medications not allowed?

DB Period and OLE Period Signup and view all the answers

What is the criteria for exclusion of certain medications during the study?

Half-life of the drug Signup and view all the answers

What happens if a participant is taking a medication that is not allowed during the study?

They need to taper off the medication under Medical Monitor's guidance Signup and view all the answers

How many standard units of alcohol are subjects permitted to consume per day?

2 standard units Signup and view all the answers

How long must subjects have been on a stable dose of oral antidepressant medication by the time of Screening?

≥6 weeks Signup and view all the answers

What information should be included in the documentation for each medication?

The trade or generic name, the total daily dose, the route of administration, and the reason for use Signup and view all the answers

What is not permitted during the DB Period of the study?

Taking more than 1 oral antidepressant medication Signup and view all the answers

What should be done with as-needed prescriptions during the trial?

They should be converted to reflect the actual dose taken per day Signup and view all the answers

What can be adjusted or switched in the OLE Period according to the Investigator's clinical judgment?

The subject's oral antidepressant medication Signup and view all the answers

What type of medications are prohibited during the DB Period and OLE Period of the study?

Anxiolytics, sedatives, and hypnotics Signup and view all the answers

Why must subjects taper-off other medications if they are taking more than 1 oral antidepressant?

Clinically appropriate, as specified in the protocol Signup and view all the answers

What is required for chronic users of benzodiazepines, benzodiazepine-like drugs, and/or prescription sleeping aids?

A tapering and washout period Signup and view all the answers

Why are COVID-19 vaccines recorded as concomitant medication?

As part of the study's safety monitoring Signup and view all the answers

Who decides the length of the tapering schedule and washout period for chronic users of prohibited medications?

The Investigator in conjunction with the prescribing physician Signup and view all the answers

When should episodic users of benzodiazepines, benzodiazepine-like drugs, and/or prescription sleeping aids undergo a washout period?

During the Screening Period Signup and view all the answers