Effect of Zuranolone on Concurrent Anxiety and Insomnia Symptoms in Women With Postpartum Depression.

Abstract

Objective: Concurrent anxiety and/or insomnia symptoms in women with postpartum depression (PPD) are common and associated with more severe PPD. The effects of zuranolone on concurrent anxiety and/or insomnia symptoms and on patient-perceived functional health in women with PPD in the ROBIN study are reported.

Methods: The phase 3, double-blind, randomized, placebo-controlled trial (conducted January 2017-December 2018) included women aged 18-45 years, ≤ 6 months postpartum, with PPD (onset of DSM-5-defined major depressive episode in the third trimester or ≤ 4 weeks postpartum) and baseline 17-item Hamilton Depression Rating Scale (HDRS-17) total score ≥ 26. Women were randomized 1:1 to once-daily oral zuranolone 30 mg (n = 77) or placebo (n = 76) for 14 days with follow-up through day 45. Concurrent remission of depressive and anxiety symptoms (Hamilton Anxiety Rating Scale total score ≤ 7 plus HDRS-17 total score ≤ 7 or Montgomery-Asberg Depression Rating Scale total score ≤ 10), improvement in insomnia symptoms, patient-perceived functional health, and treatment effect sizes described by number needed to treat (NNT) were assessed. Analyses were exploratory; P values are nominal.

Results: Rates of concurrent remission of depressive and anxiety symptoms were higher with zuranolone versus placebo (P < .05) at days 3, 15, and 45; the rate of sustained concurrent remission (ie, at both days 15 and 45) was also higher with zuranolone (P < .05). Anxiety symptoms (assessed by HDRS-17 anxiety/somatization subscale and Edinburgh Postnatal Depression Scale anxiety subscale) improved with zuranolone versus placebo (P < .05) at days 3 through 45. Potential benefits on insomnia symptoms and patient-perceived functional health were observed. Day 15 NNTs were 5 for both HDRS-17 response and remission.

Conclusions: Zuranolone was associated with concurrent improvements in depressive and anxiety symptoms, with beneficial effects on insomnia symptoms and patient-perceived functional health in adults with PPD.

Trial Registration: ClinicalTrials.gov identifier: NCT02978326.

• Authors: Kristina M Deligiannidis, Leslie Citrome, Ming-Yi Huang, Sarah Acaster, Moshe Fridman, Vijayveer Bonthapally, Robert Lasser, Stephen J Kanes
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 84 Issue 1 (01 30 2023) ISSN: 1555-2101 [Electronic] United States
• PMID: 36724109 (Publication Type: Randomized Controlled Trial, Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Copyright 2023 Physicians Postgraduate Press, Inc.

Chemical References

• zuranolone

Topics

• Adult
• Humans
• Female
• Depressive Disorder, Major (drug therapy)
• Sleep Initiation and Maintenance Disorders (drug therapy)
• Depression, Postpartum (drug therapy)
• Anxiety (drug therapy)
• Double-Blind Method
• Treatment Outcome
• Psychiatric Status Rating Scales