In October 2004, the U.S. Food and Drug Administration (FDA) issued an advisory that antidepressants may be associated with an increased risk of suicidal thoughts and behaviors in children and adolescents. These warnings were prompted by its meta-analysis of all available randomized trials of antidepressants in this age group, in which patients randomized to antidepressants had nearly twice the rate of suicidal ideation or behavior relative to those given placebo. However, following the warnings clinicians, policymakers, and patients still need guidance on important treatment questions. We propose pooling 3 large cohorts of patients who initiated antidepressant therapy (Medicaid <65; Medicare 65+, and a province-wide population-based cohort in British Columbia) and link that use to data on their health care utilization. We will employ several innovative analytic methods to produce data that will help guide treatment choices. Specifically, we will answer the following research questions: 1) Identify the rates of suicidality in users of antidepressants in terms of class, specific agents, dosages, and durations of use. 2) Identify sociodemographic, clinical, and concomitant treatment factors that may modify the relationship between antidepressant use and suicidality. 3) Identify the impact of FDA actions on antidepressant utilization and clinical outcomes. 4) Identify patterns and potentially modifiable determinants of patient monitoring after initiation of therapy to help design and target future risk management interventions. 5) Assess and improve the accuracy of coding attempted suicide in hospital and emergency room admissions. This large pharmacoepidemiologic study by an experienced interdisciplinary team using multiple analytic methods will assess the most critical issues surrounding the safety of antidepressant therapy, and will provide guidance to develop and target better prescribing and risk management strategies. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01MH078708-02
Application #
7290379
Study Section
Special Emphasis Panel (ZMH1-ERB-W (07))
Program Officer
Rubio, Mercedes
Project Start
2006-09-26
Project End
2010-07-31
Budget Start
2007-08-01
Budget End
2008-07-31
Support Year
2
Fiscal Year
2007
Total Cost
$370,503
Indirect Cost
Name
Brigham and Women's Hospital
Department
Type
DUNS #
030811269
City
Boston
State
MA
Country
United States
Zip Code
02115
Huybrechts, Krista F; Schneeweiss, Sebastian; Gerhard, Tobias et al. (2012) Comparative safety of antipsychotic medications in nursing home residents. J Am Geriatr Soc 60:420-9
Patrick, Amanda R; Miller, Matthew; Barber, Catherine W et al. (2010) Identification of hospitalizations for intentional self-harm when E-codes are incompletely recorded. Pharmacoepidemiol Drug Saf 19:1263-75
Schneeweiss, Sebastian; Patrick, Amanda R; Solomon, Daniel H et al. (2010) Variation in the risk of suicide attempts and completed suicides by antidepressant agent in adults: a propensity score-adjusted analysis of 9 years' data. Arch Gen Psychiatry 67:497-506
Schneeweiss, Sebastian; Patrick, Amanda R; Solomon, Daniel H et al. (2010) Comparative safety of antidepressant agents for children and adolescents regarding suicidal acts. Pediatrics 125:876-88
Schneeweiss, Sebastian; Setoguchi, Soko; Brookhart, M Alan et al. (2009) Assessing residual confounding of the association between antipsychotic medications and risk of death using survey data. CNS Drugs 23:171-80
Gagne, Joshua J; Patrick, Amanda R; Wang, Philip S et al. (2009) Health advisories and patterns of patient monitoring among new users of antidepressant medications. J Clin Psychopharmacol 29:590-4
Rassen, Jeremy A; Brookhart, M Alan; Glynn, Robert J et al. (2009) Instrumental variables II: instrumental variable application-in 25 variations, the physician prescribing preference generally was strong and reduced covariate imbalance. J Clin Epidemiol 62:1233-41
Schneeweiss, Sebastian; Rassen, Jeremy A; Glynn, Robert J et al. (2009) High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology 20:512-22
Rassen, Jeremy A; Brookhart, M Alan; Glynn, Robert J et al. (2009) Instrumental variables I: instrumental variables exploit natural variation in nonexperimental data to estimate causal relationships. J Clin Epidemiol 62:1226-32