NEU30009: Neuropsychopharmacology - Investigational Drug Case Study - Nursing Assignment Help

Assignment Task:

You are to construct a simple study to address a specific question regarding the cognitive effect of an existing investigational product. As background you will need to refer to the early material presented in tutorials and lectures on basic neuropharmacology, neuroimaging in psychopharmacology, cognitive assessment and clinical trial design. 

1. 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).

2. 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 related to cognition or behaviour. Describe any secondary outcomes if applicable. 

3. Detail a proposed design, and justify, considering the strengths and weaknesses of the methods used. You will need to include: a. 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) 

4. In writing up your study ensure it is well organized into sections with appropriate headings. One example might be:

a. Overview of investigational drug and its potential clinical utility

b. Investigational hypothesis regarding specific clinical effect (this is where you would detail your primary and secondary outcome measures) 

c. Overview of proposed study design

d. Methods

i. Study population

ii. Study inclusion and exclusion criteria

iii. Study design

iv. Data collection/acquisition

v. Data analysis 

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