Vagus nerve stimulation as adjunctive therapy in patients with difficult-to-treat depression (RESTORE-LIFE): study protocol design and rationale of a real-world post-market study

Autor: Renske De Zwaef, Allan H. Young, Koen Demyttenaere, Mario F. Juruena
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Pediatrics
medicine.medical_specialty
STAR-ASTERISK-D
Vagus Nerve Stimulation
lcsh:RC435-571
Bipolar disorder
medicine.medical_treatment
Major depressive disorder
VALIDATION
Difficult-to-treat depression
Study Protocol
Pharmacotherapy
MIRTAZAPINE
lcsh:Psychiatry
VNS
Clinical endpoint
MANAGEMENT
Medicine
Humans
Prospective Studies
Depression (differential diagnoses)
SCALE
Psychiatry
Depressive Disorder
Major
Science & Technology
business.industry
Depression
Study design
CARE
medicine.disease
Psychiatry and Mental health
Real-world setting
Treatment Outcome
Montgomery–Åsberg Depression Rating Scale
Vagus nerve stimulation therapy
Quality of Life
TREATMENT-RESISTANT DEPRESSION
Treatment-resistant depression
business
OUTPATIENTS
Life Sciences & Biomedicine
RESTORE-LIFE
Vagus nerve stimulation
Zdroj: BMC Psychiatry
BMC Psychiatry, Vol 20, Iss 1, Pp 1-12 (2020)
ISSN: 1471-244X
Popis: Background Depressive illness is associated with significant adverse consequences for patients and their families, and for society. Clinical challenges are encountered in the management of patients suffering from depression whether they are designated difficult-to-treat or treatment-resistant. Prospective serial depression treatment trials have shown that less than 40% of patients with major depressive disorder remit with an initial pharmacotherapy trial, and a progressively smaller proportion of patients remit with each subsequent trial. For patients who suffer from difficult-to-treat depression (DTD), treatments should focus on patient-centred symptom control, patient functioning, and improving patient quality of life. Among the treatment options for patients with DTD is Vagus Nerve Stimulation (VNS) Therapy. VNS Therapy involves intermittent electrical stimulation of the left cervical vagus nerve and has been shown to be efficacious for long-term management of patients with DTD. Methods RESTORE-LIFE is a prospective, observational, multi-site, global post-market study intended to assess short-, mid-, and long-term effectiveness and efficiency outcomes in a ‘real-world’ setting among patients with DTD treated with adjunctive VNS Therapy. A minimum of 500 patients will be implanted with a VNS Therapy System at up to 80 global sites. Eligible patients will participate in a baseline visit between 1 and 6 weeks before device implant and will be followed for a minimum of 36 months and a maximum of 60 months. The diagnosis of depression and comorbid disorders will be determined using the Mini-International Neuropsychiatric Interview (MINI). The primary endpoint is response rate, defined as a decrease of ≥50% in Montgomery Åsberg Depression Rating Scale (MADRS) total score from baseline to 12 months post-implant. Discussion A standardized approach in the management of DTD may not be appropriate for the treatment of such a complex heterogenous patient population. This study has been designed to evaluate whether VNS Therapy meaningfully improves and sustains clinical and depressive symptom outcomes in patients with DTD. This study will investigate the durability of VNS response in DTD and utility of VNS for long-term disease management of DTD. In addition, the study results will potentially clarify clinical, functional, and health economic questions in a real-world patient population with DTD. Trial registration ClinicalTrials.gov NCT03320304. Registered 25 October 2017
Databáze: OpenAIRE
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