This application requests supplemental funding for the last three months of the approved project period plus an additional 18 months. In July 1984 we were awarded a three-year grant to develop an innovative method of postmarketing surveillance of selected antidepressant drugs. Initial results using patients from the University of Texas Medical Branch (UTMB) pharmacies indicated that this patient self-monitoring system might prove to be a promising complement to existing physician-based surveillance systems in detecting adverse. drug reactions (ADRs). In 1987 we were awarded a five year competitive renewal to support a statewide field test, but numerous problems were quickly encountered, particularly in respect to patient recruitment. For the next three years we fell behind considerably in patient recruitment. These methodological problems have now been solved, but it has only been this past year that we have been able to recruit valid patients at a rate consistent with our initial proposal. In collaboration with more than 1600 Eckerd Drug Company pharmacies, we are currently recruiting between 100-200 patients per week monitoring fluoxetine, and therefore should be able to complete this important study with our original goal of approximately 10,000 patients by June 1993 -- if we have the funds to support the project for another 18 months after the current project period. If supplemental NIMH core funds are not awarded by April 1, 1992, we will clearly not have enough personnel and patient compensation money to complete the required data collection, and we will be forced to terminate the project prematurely in December 1992. Without additional core support at this crucial stage, it is very likely that much or all of our efforts over the past seven years will have been wasted and the concept of patient self-monitoring of psychotropic drug effects may never receive an adequate empirical test.
| Fisher, S; Bryant, S G; Solovitz, B L et al. (1987) A patient-initiated postmarketing surveillance system. Psychopharmacol Bull 23:400-4 |
| Solovitz, B L; Fisher, S; Bryant, S G et al. (1987) How well can patients discriminate drug-related side effects from extraneous new symptoms? Psychopharmacol Bull 23:189-92 |
| Bryant, S G; Fisher, S; Kluge, R M (1987) Increased frequency of doxycycline side effects. Pharmacotherapy 7:125-9 |
| Fisher, S; Bryant, S G; Solovitz, B L et al. (1987) Patient-initiated postmarketing surveillance: a validation study. J Clin Pharmacol 27:843-54 |
| Bryant, S G; Fisher, S; Kluge, R M (1987) Long-term versus short-term amitriptyline side effects as measured by a postmarketing surveillance system. J Clin Psychopharmacol 7:78-82 |
| Fisher, S; Bryant, S G; Kluge, R M (1986) Measuring adverse drug reactions in a postmarketing surveillance system. Psychopharmacol Bull 22:272-7 |
| Fisher, S; Bryant, S G; Kluge, R M (1986) New approaches to postmarketing surveillance. Psychopharmacology (Berl) 90:347-50 |
