Studies & Clinical Trials
- International Society for Bipolar Disorders (ISBD)
A three-year, $600,000 ISBD grant will fund a first-of-its-kind multi-national database that can be used to help researchers address questions about bipolar disorder throughout the adult lifespan.
Under the grant, investigators will aggregate and standardize data from more than 1,000 bipolar patients worldwide who have been previously studied. Most findings from these studies are based on research samples of no more than 50 participants from a relatively narrow geographic and age representation. By creating a single comprehensive data set, the scientific team aims to overcome these shortfalls and increase knowledge about bipolar disorder, its symptoms, and changes in behavior at different stages of life.
- Bipolar Biomarkers
This one-year project, done as a partnership between Case Western Reserve University and Taipei Medical University (TMU) will enroll individuals with serious mental illness and conduct a cross-sectional analysis to evaluate the relationship between brain alteration, inflammatory markers and clinical features. The psychiatric sample will be compared to a sample of approximately 60 age- and sex-matched healthy controls. Data collection and analysis will be conducted at TMU. Findings are expected to inform future collaborative research efforts between investigators at TMU and Case Western Reserve University.
- Adolescent Bipolar Disorder
The most common onset of bipolar disorder (BD) is during late adolescence and early adulthood. While pharmacotherapy is effective for BD symptoms in adolescents and young adults (AYA), poor adherence occurs in more than 65 percent of AYAs and is associated with low rates of recovery, high rates of relapse and a 5.2 fold increase in suicide risk. Poor adherence is a critical yet modifiable risk factor of poor outcomes in AYAs with BD. AYAs are an ideal BD subgroup to target and test adherence interventions given the potential impact of enhanced adherence on social, educational and occupational goals during this critical developmental period which can lay the foundation for lifelong BD self-management skills. To date, there are no interventions that specifically target adherence in AYAs with BD.
This three-phase project will identify relevant characteristics of AYAs and needed refinements to CAE (Phase 1) and standardize the intervention using iterative refinements based on patient feedback (Phase 2). Phases 1 and 2 are completed. In Phase 3 (months 13-36) we will test the feasibility, acceptability and preliminary efficacy of the adapted approach using a randomized controlled trial (RCT) design in a high-risk, high-need group: AYAs ages 16-21 with BD who are poorly adherent with prescribed BD medications. If proven effective, the proposed trial will pave the way for a rigorous efficacy trial of CAE-AYA.
- Epilepsy Self-Management
In spite of advances in biological therapies, many people with epilepsy have poor outcomes including negative health events (NHEs) such as frequent seizures, accidents and emergency department visits, and low quality of life. Risk factors for poorly controlled epilepsy include limited social supports, poor medication adherence, and comorbidities like mental illnesses. People with epilepsy who live in rural or under-served communities face additional challenges such as social isolation, limited access to care and low levels of epilepsy awareness. The Managing Epilepsy Well (MEW) Network has been a national leader in developing, testing and disseminating evidence-based epilepsy self-management programs. One of these, Self-management for people with epilepsy and a history of negative health events (SMART) is an online, group-format program that has been demonstrated to reduce NHEs and improve quality of life and physical and mental health functioning in individuals with epilepsy.
This two-site, five-year prospective randomized controlled trial (RCT) will investigate the effects of the SMART program among people with epilepsy who have had recent NHEs vs. a six-month wait-list control. The RCT will be conducted in Ohio and in Iowa, led by a team from Case Western Reserve University in Cleveland and from the University of Iowa, in Iowa City, Iowa, in collaboration with local and regional epilepsy care stakeholders and partners. Key foci of the study are to replicate the efficacy findings of the original SMART study and to obtain new information on how SMART is perceived among people with epilepsy, their families, clinicians and other stakeholders in rural and underserved communities.
- Stroke Risk Reduction in African-American Men (TEAM2)
African-Americans (AA) have substantially higher stroke rates, compared to any other racial-ethnic group. Racial disparities in stroke outcomes are particularly high among AA men. The proposed project will test a nurse and patient co-led curriculum-guided self-management support approach, Targeted Management (TEAM) focused specifically on AA men at high risk for stroke. If previously conducted pilot results can be confirmed, TEAM represents a practical approach suitable for broad scale-up, with the potential to reverse the unacceptably high morbidity seen in AA men due to stroke. NCT04402125
- Using mHealth to improve adherence and reduce blood pressure in individuals with hypertension and bipolar disorder
While cardiovascular disease remains a significant burden in the U.S., effects are particularly pronounced in people with mental disorders such as bipolar disorder (BD). Medical complications and early mortality in those with BD and hypertension is often associated with poor medication adherence and sub-optimal engagement in care. However, medication non-adherence among such individuals and its negative impact on both cardiovascular and mental health is a potentially modifiable problem of critical public health importance. This 5 year study, funded by the National Heart Blood and Lung Institute (NHLBI), will evaluate the effects of a personalized patient-centered adherence m-Health intervention called Individualized Texting for Adherence Building-Cardiovascular; iTAB-CV (iTAB-CV) on adherence to antihypertensive medications and systolic blood pressure in people with BD. NCT04675593
- Effectiveness RCT of Customized Adherence Enhancement
A cornerstone of treatment uniformly recommended for individuals with bipolar disorder (BD) is mood stabilizing medication. However, approximately one in two individuals with BD are non -adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence in BD. Customized Adherence Enhancement (CAE), developed by this study team, is a brief, practical BD –specific approach that identifies individual adherence barriers and then targets these areas for intervention using a flexibly-administered modular format. This Type 1 hybrid effectiveness-implementation project, funded by the National Institute of Mental Health (NIMH), will adapt CAE for use in community/public-sector care settings, test effectiveness in high-risk, poorly adherent individuals in these settings, and gather evidence on barriers and facilitators to implementation of the intervention. NCT04622150