Choose an investigational drug: An investigational drug may be either a drug currently in development or being trialled (typically Phase II or III) or it may correspond to an already existing pharmaceutical agent that is being investigated for “off-label” (i.e. unapproved) clinical use (e.g. ketamine in depression). A good place to start for a list of investigational drugs is(Pharmaceutical Research and Manufacturers of America – Medicines in Development).
Specify, and justify, a primary outcome measure i.e. an outcome that the investigator considers to be the most relevant and important among the possibly many outcomes that could be measured. Make sure the primary outcome measure is assessing some aspect of cognition or behaviour.
Detail a proposed design, and justify, considering the strengths and weaknesses of the methods used. In particular you will need to include:
An overview of the design
b. Study population size and constitution (gender, age)
c. Study inclusion and exclusion criteria relevant to the investigational
drug being studied
d. Methods utilised to measure drug effect (neuroimaging, biochemical
tests, cognitive and behavioural assessments)
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