Patient-reported health-related quality of life from a randomized, placebo-controlled phase 2 trial of zuranolone in adults with major depressive disorder.

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.

• Authors: Ellison Suthoff, Mark Kosinski, Alix Arnaud, Paul Hodgkins, Handan Gunduz-Bruce, Robert Lasser, Christopher Silber, Abdul J Sankoh, Haihong Li, Brian Werneburg, Jeffrey Jonas, James Doherty, Stephen J Kanes, Vijayveer Bonthapally
• Journal: Journal of affective disorders (J Affect Disord) Vol. 308 Pg. 19-26 (07 01 2022) ISSN: 1573-2517 [Electronic] Netherlands
• PMID: 35378149 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.

Chemical References

• Pregnanes
• Pyrazoles
• zuranolone

Topics

• Adult
• Depressive Disorder, Major (drug therapy, psychology)
• Humans
• Pain
• Patient Reported Outcome Measures
• Pregnanes
• Pyrazoles
• Quality of Life (psychology)
• Surveys and Questionnaires