Short Answer Case Study (Bioethics class)
Question: What would be the researcher’s goals for this Phase IIIdrug trial?
Upon inspecting his schedule for the day, psychiatrist DavidKimball was surprised to learn that his first patient of themorning was Geoffrey Allen. Geoff had been in for an appointmentless than 2 weeks ago to discuss his response to a monoamineoxidase inhibitor (MAOI) as a treatment for chronic depression. Atthe time, it seemed as though the medication was working, a relieffor both Geoff and Dr. Kimball after several years of searching forthe right way to manage Geoff’s illness.
Geoff had been referred to Dr. Kimball’s practice by StudentHealth during his freshman year. After discussing Geoff’s symptomsof insomnia, lethargy, and weight loss as well as learning of afamily history of depressive disorders, Dr. Kimball prescribed thefirst of what would be a long list of medications. Through thecourse of his magna cume laude degree in political scienceand now into his doctoral dissertation, Geoff had tried severaltricyclic antidepressants, selective serotonin reuptake inhibitors,and second-generation antidepressants. While he would have periodsof stability ranging from a few weeks to a few months as in thecase of fluoxetine, eventually either the medication stoppedworking or the side effects became too bothersome.
At his last appointment, Dr. Kimball had been pleased withGeoff’s clinical response to the MAOI, even though a brief physicalexam revealed the presence of mild orthostatic hypotension. Whenqueried, Geoff himself said he felt better than he had in monthswith the exception of the fact that he and his girlfriend were lessthan thrilled about the side effects. In response, Dr. Kimballadjusted the prescription and reminded Geoff not to hesitate toschedule another appointment if things changed.
“Well, you’re always reminding me to come to see you ifsomething comes up,” Geoff said when Dr. Kimball asked about thepurpose of Geoff’s visit, “and there’s something I need to talkabout. I’m starting to feel tired again like I have no energy, andmy motivation to do things is slipping. My girlfriend is telling methat things have to change or she is going to leave me.” Geoff wenton to describe an elevation in his depressive symptoms as well as agrowing dissatisfaction with the MAOI side effects. Dr. Kimball iscurrently conducting a Phase III drug trial for a drug called Licol, a new lithium-based antidepressant, which has shown great promisefor the treatment of atypical depression, especially in youngeradults. However, these clinical trials for the medication utilizeddouble-blind placebo controls. Also, data was not yet availableconcerning the follow-up treatment of patients who withdrew fromthe trials. Dr. Kimball thinks that Geoff would be a goodparticipant in this study and is considering talking to Geoff aboutbecoming a participant.
