AI Article Synopsis
- Major depressive disorder (MDD) significantly impacts health-related quality of life (HRQoL), and this study examined how the neuroactive steroid zuranolone affects HRQoL using the Short Form-36v2 Health Survey (SF-36v2).
- Adult patients with MDD were randomly assigned to receive either zuranolone or a placebo for two weeks, with HRQoL assessed across various domains at Day 15 showing substantial improvements for those treated with zuranolone, particularly in areas like Mental Health and Vitality.
- The results suggest that zuranolone leads to rapid and meaningful HRQoL enhancements compared to placebo, although the small sample size may limit generalizability and other factors could influence HRQoL
Article Abstract
Background: Major depressive disorder (MDD), a disabling, potentially life-threatening condition, negatively affects health-related quality of life (HRQoL). This secondary analysis aimed to understand the impact of the neuroactive steroid zuranolone on HRQoL using the Short Form-36v2 Health Survey (SF-36v2).
Methods: Adult patients with MDD and 17-item Hamilton Rating Scale for Depression total score ≥22 were randomized 1:1 to receive zuranolone 30 mg or placebo for 2 weeks, with 4 weeks follow-up. SF-36v2 scores were assessed at Day 15 across 8 domains (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health) and 2 summary scores (Physical and Mental Component), using a mixed-effects model for repeated measures. Correlations between SF-36v2 scores and clinician-reported efficacy endpoints were assessed using Pearson's correlation.
Results: Eighty-nine patients were treated with zuranolone 30 mg (n = 45) or placebo (n = 44). In zuranolone-treated patients, HRQoL improved across all SF-36v2 domains and summary scores at Day 15. Improvements exceeding established minimally important difference thresholds were observed in Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health scores. Improvements in General Health, Vitality, Mental Health, and Mental Component Summary were statistically significant versus placebo (p ≤ 0.025). Clinician-rated endpoints negatively correlated with SF-36v2 scores.
Limitations: The small unipolar depression sample may not be representative of all US MDD patients. HRQoL measures could be impacted by factors unrelated to depression.
Conclusions: Zuranolone-treated patients reported rapid and significant improvements in HRQoL versus placebo at Day 15. HRQoL improvements correlated with improvements in clinician-rated assessments.
Trial Registration: clinicaltrials.gov:NCT03000530; https://clinicaltrials.gov/ct2/show/NCT03000530.
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| http://dx.doi.org/10.1016/j.jad.2022.03.068 | DOI Listing |
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