Abbott has commenced a pivotal clinical trial to assess its deep brain stimulation (DBS) system in managing treatment-resistant depression (TRD).
The Treatment ResistAnt DepressioN Subcallosal CingulatE Network DBS (TRANSCEND) study aims to enrol 100 participants who have not responded to at least four different anti-depressant treatments.
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In this double-blind, sham-controlled, randomised, prospective, multi-centred trial, participants aged 22 to 70 years will be assigned randomly to either the treatment or control arm at up to 25 centres across the nation.
The primary measure of success will be the change in Montgomery-Asberg Depression Rating Scale (MADRS) scores over 12 months.
Following this period, all participants will receive active DBS and be monitored for an additional two years.
DBS operates similarly to a pacemaker, delivering targeted electrical pulses to brain areas associated with depression.
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By GlobalDataIn the TRANSCEND study, electrodes will be implanted in the brain and connected to a stimulator in the chest to alleviate depressive symptoms.
Previous studies have indicated that DBS can lead to a sustained improvement in depression symptoms for a significant proportion of participants over several years.
In 2022, the DBS system secured breakthrough device designation from the US Food and Drug Administration (FDA) to improve treatment for life-threatening or irreversibly debilitating conditions.
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.”
Last month, the FDA approved a label change for Abbott’s HeartMate 3 left ventricular assist device, eliminating the need for aspirin use as part of routine patient management.
