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Abstract - Final

Addressing Knowledge Gaps in the Treatment of Depression

Topic Abstract

Comparative evidence for the effectiveness and harms of second-generation antidepressants (SGAs) is conflicting or nonexistent regarding treatment-resistant and recurrent depression. In particular, when a patient fails to respond to an initial treatment, current data do not suffice to determine whether changing the antidepressant or adding a second treatment is preferred. It is also unclear whether comparative effectiveness differs among patients with accompanying symptoms, including anxiety, insomnia, and fatigue. Our goal is to address these important knowledge gaps in depression treatment by conducting secondary analyses of data from the Sequenced Treatment Alternatives to Relieve Depression (STAR-D) trial — the nation's largest real-world depression treatment trial involving over 4,000 patients in a sequence of randomized controlled trials to define preferred treatments for treatment-resistant depression. We shall compare switch and augment strategies by using propensity scores to minimize potential bias among unrandomized subgroups in the STAR-D trial. Our key questions are:

  1. Are outcomes better following a medication switch compared with augmentation with a second medication?
  2. Do the incidence and tolerability of specific adverse events differ following specific SGA monotherapy or combinations?
  3. Does health care utilization differ following specific SGA monotherapy or antidepressant combinations?
  4. Does the presence of accompanying symptom clusters differentiate the comparative effectiveness of SGAs for treating depression?

Our research questions and study design draw upon continuous feedback from stakeholders representing patients (National Alliance on Mental Illness), health care providers (American Psychiatric Association and the North American Primary Care Research Group), and policy-makers, including the Drug Effectiveness Review Project (a consortium of Medicaid agencies and other public payers) and the Academy of Managed Care Pharmacy (which represents managed care decision-makers, including Medicare Part D plans). We shall work with stakeholders to translate the available evidence of the highest quality into information upon which they can act. This ongoing feedback from stakeholders will allow us more clearly to outline the key relevant next steps in making evidence-based decisions on antidepressant treatment.