Almost 15 million adults in the U.S. suffer from major depressive disorder and the World Health Organization (Geneva, Switzerland) considers the condition the leading cause of disability. Yet only two-thirds of those who seek treatment (many do not) in the form of medication and therapy are helped. The remaining one-third continue to suffer and are subsequently labeled with treatment-resistant depression (TRD).

Some of the best minds in the business are joining forces to develop performance improvement initiatives to better identify, diagnosis and manage people living with TRD.

"Clinically, we've found that if you go after the people with TRD to test more treatment combinations, they do better. But, if you only get them partly better, they get much worse in the end," Glenn Treisman, MD, PhD, professor of psychiatry and behavioral sciences and medicine, Johns Hopkins University (Baltimore) School of Medicine, told Medical Device Daily.

Treisman is part of the new initiative seeking to develop guidance and answers on how best to treat patients with TRD. In addition to Johns Hopkins, other groups involved include the Depression and Bipolar Support Alliance (DBSA; Chicago), Baylor College of Medicine (Houston) and MJ Consulting Group (Jersey City, New Jersey), which is acting as the coordinator. The alliance will develop continuing education and a performance improvement initiative designed for all healthcare providers, such as primary care physicians, nurse practitioners, physician assistants and psychiatrists.

MJ Consulting, a company that specializes in healthcare education strategy, identified the gap in therapy options for TRD and initiated conversations with people at Hopkins, said Seanne Murray, CEO of MJ Consulting.

"Our main goals are to address the unmet needs of patients with TRD, the lack of knowledge of the epidemiology of TRD in clinical practice, the lack of recognition and accurate diagnosis and lack of awareness of appropriate steps to take," Murray told MDD.

Through inter-organizational collaboration, the group hopes to develop appropriate therapeutic strategies that do not exist today. The initiative will provide patient-level outcomes, through a performance improvement component, using nationally recognized clinical measures on how education was able to improve healthcare provider knowledge, skill and competency.

"Our group wants to get together to compare experiences with these difficult-to-treat patients and come up with reasonable questions such as where you would draw the line and how far you go in trying new treatments and what people should be doing that they're not doing," Treisman said.

Treisman explained that he recently treated a patient with severe cardiac disease who also had TRD. "He went through the selective serotonin reuptake inhibitors class of antidepressants and they didn't work. Everybody was afraid to give the patient tricyclic antidepressants because of his heart disease and the related risks. But that was the only drug left to try, yet nobody would give it to him because risks were so high," Treisman said. "The patient told me If I don't get better, I'm going to kill myself.' Even though there was a risk, I gave him the tricyclic medication because there was no other option. He came to me for aggressive treatment. In the end, we tried it and it worked."

These are the types of TRD cases for which there is no standard diagnostic criteria or procedures on how to treat.

"One of the key factors about this alliance is that there's a high-level collaborative leading this effort," Murray said. "It's a unique opportunity for those organizations to work together and address physician education."

The med-tech sector is also trying to address this unmet need. Treisman said devices will be reviewed and considered in the group's protocol development along with drugs and therapy.

St. Jude Medical (St. Paul, Minnesota) reported earlier this summer that the first patient was implanted in a clinical study that is investigating whether deep brain stimulation (DBS) therapy will help people who suffer from major depressive disorder. The patients were implanted with the St. Jude Medical Libra DBS system. The study, called BROADEN (BROdmann Area 25 DEep brain Neuromodulation), is evaluating the safety and effectiveness of DBS in patients with depression for whom currently available treatments are not effective (MDD, June 27, 2008).

Cyberonics (Houston) has been developing its vagus nerve stimulation system (VNS) for TRD. That use of the VNS technology – originally focused on treatment of epilepsy - has been panned by critics as a company creation of a disease target, since the term could simply be applied to any disease resistant to standard treatments. While Cyberonics won FDA approval for the TRD application, the therapy has not won acceptance in the medical and psychiatric communities, with rejection of reimbursement coverage by the Centers for Medicare & Medicaid Services being a major economic barrier.

Last August, Cyberonics said it was refocusing its efforts in the epilepsy market (MDD, Aug. 31, 2007).

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