Abbott has launched a pivotal clinical trial to see if its deep-brain stimulation approach can make headway against treatment-resistant depression.
The company previously collected green lights for brain neuromodulation systems that help treat the movement symptoms that come with Parkinson’s disease and essential tremor, as well as for implants that focus on the spinal cord to aid in cases of chronic pain. The devices send small electrical pulses to spur tissue activity, not unlike a pacemaker.
The FDA previously granted Abbott a breakthrough designation to use the same technology to target the areas of the brain that help regulate mood. Prior, open-label studies have shown that about 75% of treated patients had reported improvements in their symptom scores by at least 50% over a period of several years.
Now, the company said it will begin enrolling about 100 people in a randomized, controlled trial—specifically those who were prescribed at least four different types of antidepressant medications but did not see significant benefits.
While all will be implanted with a brain stimulator, including a pulse generator placed under the skin and electrodes wired into the skull, only half will start the study with their devices turned on. After 12 months, all participants will receive the neuromodulation therapy and they will be followed for another two years.
Abbott estimates that as many as 2.8 million people in the U.S. have treatment-resistant cases or about one-third of all people diagnosed with major depressive disorder.
In a separate study published last year, backed by the National Institutes of Health, researchers were able to identify a biomarker within neural activity data recorded from deep-brain stimulation study participants—one that correlated with significant changes in their depression symptoms as they responded to treatment.
They also found the approach worked both ways, allowing them to spot the signs that a patient’s depression may start worsening and giving them the opportunity to adjust their neurostimulation doses.