Theme 1. Mental health and addictions
Participants will learn about the prevalence of depression in older adults. The definition and diagnosis of treatment-resistant depression (TRD) in older adults will then be discussed with emphasis on the consequences of persistence of depression in older adults, including high burdens on caregivers, morbidity, and mortality (including suicide).
Participants will then be oriented to a new research project that aims to fill the evidence gap around treatment of late-life depression with focus on different pharmacotherapy options (augmentation versus switching medications) and how aging may change the risk versus benefit ratio of these options. Challenges of implementing a large-scale, multi-site study will also be discussed along with strategies for recruiting physician and patient participants to the study.
Statement of Purpose: Treatment-resistant depression (TRD) is a major health problem for the aging population: in most older adults, depression fails to remit with first-line antidepressant pharmacotherapy. Older adults with persistent depression experience significant medical consequences, place high burdens on caregivers, and suffer high suicide rates. Making it worse is the paucity of evidence-based treatments at a stage in life when medications benefit vs. risk ratio is crucial.
OPTIMUM is a five city (4 US and 1 Canadian) large study that will use both quantitative and qualitative methods. It includes a pragmatic, adaptive randomized controlled trial (RCT) to evaluate the comparative benefits and risks of antidepressant strategies (augmentation versus switching medications) and how aging changes this balance of benefits and risks.
Methods: OPTIMUM will randomize 1500 older adults aged 60+ to 10 weeks of one of three treatment strategies: aripiprazole augmentation, bupropion augmentation, or switch to bupropion. Participants who fail to remit will be randomized again following a step-wise treatment progression to one of two treatment strategies: augmentation with lithium or switch to nortriptyline. Participants who complete acute treatment will be followed for one year. This pragmatic RCT will be carried out in real-world primary care clinical settings and psychiatric clinics in Ontario. Primary care providers will provide treatments, with decision support from the study team. Stakeholder engagement including patients and professional or family caregivers will ensure the study methods and results are relevant to both patients and providers.
Results: We will report on the challenges and results of operationalizing OPTIMUM with respect to REB and Health Canada approval, implementation of OPTIMUM across various primary care settings in Ontario, physician and patient recruitment strategies, partnerships and progress to date.
Conclusions: Operationalizing pragmatic studies in primary care require attention to a variety of barriers and enablers which will be discussed during the presentation.