Recent data from the National Institutes of Health shows more than 16 million American adults over age 18 had at least one major depressive episode in the previous year.

The condition, known as major depressive disorder (MDD), is characterized by a depressed mood or a loss of interest in activities for at least two weeks that impairs a person’s social, occupational or educational functions.

About 7 million Americans with MDD are treated with first-line antidepressant medications. However, the therapy doesn’t work for about 4 million of those patients, who then try second-line medications. Still, that therapy doesn’t work for about 3 million people. 

Treatment-resistant depression

When two lines or more of antidepressant therapies fail to work, those patients are diagnosed with treatment-resistant depression (TRD).

Patients with TRD are typically prescribed antidepressants, talk therapy and other treatments, hoping for something to work.

The treatment approach has been, “trial and error with great difficulty,” says Charles B. Nemeroff, M.D., Ph.D., the chief of psychiatry at the University of Miami Hospital.

Innovation in research

A new investigational drug — AXS-05: a novel, oral product combining existing medicines bupropion and dextromethorphan — may be a breakthrough treatment. The investigational drug is being evaluated as part of the STRIDE-1 (Symptom Treatment in Resistant Depression 1) phase 3 study.

“There haven’t been major developments in new therapies for depression therapies in years,” says Cedric O’Gorman, M.D., MBA, senior vice president of Clinical Development and Medical Affairs for Axsome Therapeutics, the company that makes AXS-05.

Treating depression

Dr. Nemeroff, who is not an advisor to Axsome Therapeutics, is enthused that new therapies are in development. He advises patients, “You can’t give up, because the odds are you’re going to respond to one treatment or another.”

His patient, Michelle Rovere, 56, has TRD and was suicidal in 2016.

“I’d become a burden to myself, to my husband, to my children,” she says, concluding, “I was in so much emotional pain.”

Rovere, who takes antidepressants, is in talk therapy and is feeling well.

“Peace and mental wellness are achievable,” she says.

Patients with MDD who are currently depressed and have failed one or two antidepressant treatments are encouraged to see if enrollment in the STRIDE-1 clinical trial may be suitable for them. https://www.trdstudy.com/