Abbott has commenced the TRANSCEND study, a prospective, multi-center, double-blind, randomized, and sham-controlled clinical trial, to evaluate the efficacy of its deep brain stimulation (DBS) system in managing treatment-resistant depression (TRD). The FDA has granted Breakthrough Device designation to Abbott's DBS system, aiming to expedite the review process for this technology intended to improve outcomes for individuals with life-threatening or irreversibly debilitating conditions.
Brian Kopell, M.D., lead neurosurgery investigator, and director of the Center for Neuromodulation at Mount Sinai Health System, noted that psychiatric diseases like major depressive disorder exhibit identifiable structural and functional changes in the brain, similar to other neurological conditions. He added that DBS research has shown promise for TRD, mirroring its success in medically complicated Parkinson's disease over the past two decades.
Understanding Treatment-Resistant Depression
TRD, a form of major depressive disorder (MDD), affects individuals who have not found relief from their symptoms despite trying various antidepressant approaches, including talk therapy, oral medications, and transcranial magnetic stimulation. Approximately 2.8 million Americans are diagnosed with TRD annually, representing up to a third of individuals with MDD. The likelihood of finding relief decreases with each failed treatment, with relapse rates reaching as high as 83% after four unsuccessful treatments.
How DBS Works
DBS functions akin to a pacemaker, delivering targeted electrical pulses to specific brain regions to alleviate symptoms. In the TRANSCEND study, electrodes will be implanted in brain areas associated with depression, connected to a stimulator placed under the skin in the chest. The stimulator emits electrical pulses to modulate brain activity and reduce depressive symptoms. Prior open-label studies suggest that DBS for TRD can lead to a sustained improvement of at least 50% in depression symptoms for three out of four individuals over two to eight years.
TRANSCEND Study Design
The TRANSCEND study will enroll 100 participants aged 22 to 70 who have failed at least four different antidepressant treatments across up to 25 centers in the United States. Participants will be randomized to either the treatment arm (DBS system activated) or the control arm (DBS system not activated). Neither the participants nor the study researchers will be aware of which group they are in.
After 12 months, all participants will have their DBS systems activated and will be followed for an additional two years. The primary outcome measure will be the change in Montgomery-Asberg Depression Rating Scale (MADRS) scores between the treatment and control groups. The MADRS assesses various depression symptoms, including sadness, appetite loss, sleep disturbances, and difficulties with concentration and daily tasks.
Pedro Malha, vice president of neuromodulation at Abbott, stated that the TRANSCEND study aims to generate clinical evidence to determine the safety and efficacy of DBS for TRD, potentially offering a new treatment option for those affected by this debilitating condition.
