The research career award would provide Dr. Ackerman with didactic and research training to conduct epidemiologic studies of treatment outcomes and clinical trials, including methods of psychiatric screening and psychological assessment, diagnostic procedures, and advanced statistical techniques. Her previous research has focused on the identification of predictors of response to psychotherapeutics by performing secondary analyses of data collected by pharmaceutical companies in randomized clinical trials (RCTs). During the first 3 years of this grant, formal course work and directed study will train Dr. Ackerman in the biological and methodological principles of clinical psychopharmacology and pharmacoepidemiology. An observational study during the fourth and fifth years will evaluate treatment response in obsessive-compulsive disorder (OCD) and extend the findings from industry-sponsored clinical trials to clinic settings. A cohort will be drawn by retrospective chart review of all patients with OCD treated in the UCLA Neuropsychiatric Hospital Mood and Anxiety Disorders Program during the previous 4 years. Two types of cohorts will be chosen. One will include all patients and will assess short and long-term outcomes of all treatments. The other will be restricted to patients who received either clomipramine or fluoxetine and will be subject to the same exclusion criteria and follow-up periods that were employed in the Phase 3 RCTs sponsored by the two drugs' developers. Results from the two cohorts will be compared with respect to predictors of all possible outcomes, including response, partial response, added medications, drop- outs. Predictors of response from the cohorts will then be compared with predictors of response that were identified by analyzing data from two Phase 3 trials of clomipramine and fluoxetine. Statistical methods will be used that can identify and resolve problems of biological heterogeneity, i.e., when people vary in their response to a particular treatment and in their risk for a given condition, and multiple- comparison artifacts that are frequently encountered in analyzing data from multicenter studies.
|Ackerman, Deborah L; Greenland, Sander (2002) Multivariate meta-analysis of controlled drug studies for obsessive-compulsive disorder. J Clin Psychopharmacol 22:309-17|