Abbott has started a clinical trial named the TRANSCEND study to assess the effectiveness of its deep brain stimulation (DBS) system for treating treatment-resistant depression (TRD).
The US Food and Drug Administration (FDA) awarded the company breakthrough device designation to explore the use of deep brain stimulation for TRD in July 2022.
TRANSCEND is intended to assess the potential of DBS to enhance treatment options for individuals with life-threatening or severely debilitating conditions.
DBS is a personalised, adjustable therapy that functions similarly to a pacemaker, delivering small, precise electrical pulses to targeted brain regions to alleviate symptoms.
In the TRANSCEND study, electrodes, referred to as leads, will be implanted in a brain area associated with depression. These leads are connected to a stimulator, which is placed under the skin in the chest.
The stimulator is designed to send electrical pulses through the leads to modulate brain activity with an aim to reduce depressive symptoms.
Abbott neuromodulation vice president Pedro Malha said: “Treatment-resistant depression is a debilitating condition affecting 2.8 million Americans each year.
“The goal of Abbott’s TRANSCEND study, in collaboration with top clinical research centres, is to develop the clinical evidence necessary to determine whether DBS is a safe and effective treatment for treatment-resistant depression, which could provide people with a new treatment option that will allow them to live fuller lives.”
The prospective, multi-centred, double-blind, randomised and sham-controlled study will involve 100 participants, aged 22 to 70, who have not responded to at least four different antidepressant treatments.
It will be conducted at up to 25 centres across the US and participants will be randomly assigned to either the treatment group or a control group.
Those in the treatment group will receive an active DBS device, while those in the control group will receive a non-active device.
After 12 months, all participants will have their DBS devices activated and will be monitored for an additional two years.
The study will measure its success by comparing improvements in depression symptoms, as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS), between the treatment and control groups.
Previous open-label studies investigating DBS for TRD have demonstrated that about three out of four patients experienced at least a 50% sustained improvement in depressive symptoms.
Last month, Medtronic secured the FDA approval of its expanded magnetic resonance imaging (MRI) labelling for its DBS systems.
