Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Bipolar disorder (BD) is a heterogeneous chronic psychiatric disorder and is among the leading causes of disability worldwide. Approximately 5.7 million people are affected with BD in the United States alone. However, which treatment works best for which patient is not well known. Comparative effectiveness evidence is lacking on long-term treatment outcomes of second-generation antipsychotics and mood-stabilizing anticonvulsants. We will address important gaps in evidence about how different subpopulations respond differently to treatment—in particular, children and adolescents, and the elderly. Better evidence about BD treatment outcomes will allow individualized pharmacotherapy for optimal disease management, reduction of short- and long-term medication side effects, and associated emergence (or worsening) of medical comorbidities.

Aim 1: Identify patient-centered outcomes of longitudinal bipolar treatment. Hypothesis: Hypothesis: Our large scale electronic record database contains information that can be utilized to generate comparative effectiveness evidence on outcomes that are important to patients with bipolar disorder.

Aim 2: Compare patient-centered outcomes for commonly prescribed bipolar medications. Hypothesis: There are significant differences in long-term outcomes for different drugs and drug combinations.

Aim 3: Assess heterogeneity of treatment effect by patient subpopulations. Hypothesis: Outcomes for the same treatments will vary by BD subtype, age, gender, comorbid conditions, and concomitant medications.

We will use a rigorous analysis process that delivers high-quality evidence from large-scale observational data, despite treatment bias and confounders.

Annually, we will engage with patient focus groups at National Alliance on Mental Illness (NAMI) Montana, NAMI Westside Los Angeles, and NAMI New Mexico to elicit research questions, assess evidence generated, and assist in dissemination of findings. The proposal was developed in concert with our Patient Partner Advisory Council, comprising patients, family of patients, patient advocates, and clinicians. Throughout the study, they will serve in an advisory capacity.

Successful completion of our project will allow BD patients to access a composite view of expected outcomes pertinent to one or several treatment options—including the option of not undergoing treatment. This information will enhance joint decision making between patients and physicians by improving the patient’s understanding of the consequences of treatments.