PCORI Board Approves $40 Million for Improving Treatment Options for Depression

ASHINGTON, D.C. (July 19, 2016) – The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved nearly $40 million to fund three studies that will compare the effectiveness of different strategies for improving care and outcomes for people with treatment-resistant depression. The awards were among 35 totaling $153 million approved today.

Nearly one-third of the 14 million Americans living with depression do not get adequate relief from their initial therapy approaches. However, there has been little research on how to best help patients with this form of the condition. 

"Treatment-resistant depression can have a devastating impact on a person’s health and well-being,” said PCORI Executive Director Joe Selby, MD, MPH. “Clinicians often don’t have a good way to predict who will respond to which therapies, so patients may have to try a range of therapies. Too often it’s a frustrating series of trial and error. These studies will provide significant new information to help patients, their families and their clinicians decide more confidently which therapy will work best given their needs and preferences.”   

The three projects approved today are:

• An $11.8 million study that compares the safety and effectiveness of electroconvulsive therapy (ECT), an existing strategy for treatment resistant depression that alleviates depressive symptoms by using an electric current, to the anesthetic drug ketamine, which has been shown to be efficacious for treatment-resistant depression but has not yet been compared to ECT. The project will focus specifically on the outcomes most important to patients: quality of life and relief from depression without the risk of significant side effects such as memory loss. The study will be led by a team based at the Cleveland Clinic.
• A $14.2 million trial that compares three strategies to address treatment-resistant depression. In one strategy, patients will take their current antidepressant supplemented with transcranial magnetic stimulation, which uses magnetic fields to stimulate nerve cells in the brain. The second strategy supplements the patient’s current medication with the drug aripiprazole. In the third, patients will switch medications to the antidepressant venlafaxine. The study based at Massachusetts General Hospital in Boston will track the severity of participants’ depression as well as their ability to function at work and home.
• A $13.9 million study will focus on antidepressant treatment strategies in older adults with treatment-resistant depression. Participants will add either the drug aripiprazole or bupropion to their existing antidepressant medications, or will switch from their existing antidepressant medication to bupropion.  For patients who do not respond to treatment during the first phase, they will take either lithium or nortripyline during a second phase.  The investigators will also explore how aging-related factors affect the benefits and risks of different antidepressant strategies.  The study, based at the Washington University School of Medicine in St. Louis, will provide information that helps older adults get effective treatment while improving their quality of life and minimizing risks of medications.

Each study involves patient organizations, major professional societies and associations, payers, or other key patient and stakeholder groups in their research design and implementation. Some of the partners include the National Institute of Mental Health, and representatives from the pharmaceutical industry.  This kind of engagement can help ensure that studies focus on the outcomes that matter most to patients and those who care for them and can facilitate quicker dissemination and application of study results.

The new studies seek to address evidence gaps and answer questions that people with treatment resistant depression and other healthcare stakeholders identified as their top priorities through PCORI’s process for topic selection. A multi-stakeholder workshop in June 2015 brought together patients and participants representing groups advancing research on chronic pain as well as clinicians, government agencies, industry, and health insurance plans to refine the questions that became the focus of PCORI’s funding announcement.  All awards are approved pending completion of a business and programmatic review by PCORI staff and completion of a formal award contract.

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About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.