Patient-Reported Outcomes on RAPID-Acting Antidepressants in Major Depressive Disorder (MDD)

Author(s)

Świder A1, Mizerska K1, Nowotarska A1, Khrouf F2
1Creativ-Ceutical, Kraków, Poland, 2Creativ-Ceutical, Tunis, Tunisia

OBJECTIVES: The response to conventional treatment for MDD is considered insufficient, as improvement of symptoms is observed after a few weeks of regular use. Approximately 50% of patients are non-responders. There is a pressing need to consider a novel approach. Rapid onset of action, along with full disease remission are priorities. The new class of substances - rapid-acting antidepressants - bring hope. In March 2019, the FDA accepted for restricted use a nasal spray with ketamine, which is the first option for treatment-resistant depression. The aim of this review was to identify patient-reported outcomes (PROs) to evaluate the response to rapid-acting antidepressants considered as a new paradigm in the treatment of MDD.

METHODS: The target literature review with the focus on selected rapid-acting antidepressants in clinical studies, systematic reviews and a meta-analysis with PROs endpoints was conducted in OVID Medline/Embase database (June 2020). The papers in English, published from 2015 year were initially reviewed. Additionally, the ClinicalTrials.gov database was evaluated.

RESULTS: The self-reported outcomes were mostly measured by patient global impression-change (PGI-C), Beck Depression Inventory (BDI) or Massachusetts General Hospital Cognitive, and Physical Functioning Questionnaire (CPFQ). The adverse effects were reported by using the Global Self Evaluation of Memory (GSE-My), the Squires Memory Complaint Questionnaire (SMCQ), and Patient Rated Inventory of Side Effects (PRISE). The efficacy of ketamine (versus a control) in reducing suicidal thoughts was considered by patients as significantly more rapid and persisted in a higher number of treated patients (up to 1 week). A deeper analysis will be provided by the end of September 2020.

CONCLUSIONS: The presented review of self-reported instruments will help to enhance understanding of instruments which can be considered in the assessment of the rapid reduction in depressive symptoms. This knowledge would be meaningful in the context of designing the upcoming clinical trials.

Conference/Value in Health Info

2020-11, ISPOR Europe 2020, Milan, Italy

Value in Health, Volume 23, Issue S2 (December 2020)

Code

PND13

Topic

Clinical Outcomes, Patient-Centered Research

Topic Subcategory

Clinical Outcomes Assessment, Patient-reported Outcomes & Quality of Life Outcomes

Disease

Drugs, Neurological Disorders

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