<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Depression Jones agreed to join an ongoing sponsored clinical trial of an investigational new agent for treatment of severe unipolar depression, directed toward persons over age 55, to include at least 40% above age 70. Previous clinical trials with this agent have studied younger persons. This drug differs from others in that it is supposed to increase limbic serotonin levels and receptors markedly and rapidly, thus relieving an entire depressive episode in two days. The drug, when administered long-term, has been shown to increase limbic system serotonin receptors as demonstrated by PET scanning. Jones was invited to participate because of her interest in clinical investigation, expertise in depression, and patient base as director of the hospital's in-patient depression unit, where she cares for the most severe cases including numerous suicide attempt survivors. The study requires that patients be severely depressed and not suffer from a chronic medical condition. The acute study will compare the new agent with established drug therapy over a three-day period. Progress will be measured using depression instruments, serotonin and serotonin metabolite measurements, as well as PET scans on day zero and three. Following the acute trial, the participants will be treated for depression free of charge for 1 year either with the new agent or a standard regimen and will have quarterly clinic follow-ups. Participants will receive a payment of $200 at the end of hospitalization, and $50 plus transportation for each of the quarterly follow-ups. Informed consent will be obtained on admission. The anticipated adverse events from studies in other subjects are limited to nausea, dizziness and thirst, never serious in the younger populations previously treated. A corporate Data and Safety Monitoring Board will monitor the study. The study will be carried out under the auspices of the GCRC but within the locked psychiatric ward, mainly on patients admitted under a 72-hour hold. Critique this study as though you are an IRB member, assessing the various review elements. Provide constructive suggestions as to how it may be improved to be more acceptable as a human subjects study. After discussion and a number of revisions the IRB finally approves the protocol. Jones undertakes the study and finds that recruitment is slow, with only 30% of eligible patients willing to participate. While the trial coordinator doesn't mention it, the Research Subject Advocate for the GCRC finds that those participants who improve clinically become progressively more reluctant to participate and have to be cajoled to continue. A subset of the subjects become agitated and some sign out against medical advice as soon as their 72-hour hold is lifted. Alarmed, Jones asks to break the randomization code and the company representative indicates that hers is the only site that has requested a code break. They reluctantly break the randomization and find that only subjects taking the experimental drug abandon the study. Jones believes, on the basis of personal experience with the patients that the drug effectively alleviates depression rapidly. As a member of the Data and Safety Monitoring Board, write a detailed justified recommendation to Jones about the continued conduct of this study. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 3 Quick Links Ethics and Study Design Introductory Ethics Design Appropriate Risk to Benefit Ratio Selection of Subject Populations Cases Bibliography Chapter 3 Download (PDF)