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Review of Allopregnanolone Agonist Therapy for the Treatment of Depressive Disorders
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Review of Allopregnanolone Agonist Therapy for the Treatment of Depressive Disorders
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Journal Article
Review of Allopregnanolone Agonist Therapy for the Treatment of Depressive Disorders
2021
Overview
This paper reviews the current literature available for the efficacy and safety of allopregnanolone agonists and discusses considerations for their place in therapy.
A literature search was conducted utilizing PubMed, clinicaltrials.gov, and the manufacturer's website.
One phase II trial and two phase III trials evaluating the efficacy and safety of brexanolone were identified. Brexanolone demonstrated efficacy through significantly reduced Hamilton Depression Rating Scale (HAM-D) scores compared to placebo in the treatment of postpartum depression (PPD). Noted adverse effects were somnolence and dizziness, excessive sedation, and loss of consciousness. One published phase II study and the interim results of two phase III trials and one phase II trial on zuranolone were included in this review. Zuranolone, an oral allopregnanolone agonist, is given as a single, 14-day course. A significant reduction in HAM-D scores was demonstrated in patients with major depressive disorder (MDD) at 15 and 28 days compared to placebo. Interim results for zuranolone in PPD and bipolar disorder (BPD) show promising reductions in HAM-D scores. Adverse effects included sedation, dizziness, and headache.
Allopregnanolone agonists seem to have a role in PPD when weighing the quick onset of action and potential risks of untreated PPD. The class of medications is limited by the single course for this indication and may fit as a bridge to maintenance therapy with selective serotonin reuptake inhibitors (SSRIs). Brexanolone, specifically, is hindered by the long infusion time, hospitalization associated with administration, and risk evaluation and mitigation strategy program. Zuranolone may also have a role in MDD or BPD, but more data are needed.
Allopregnanolone agonists present a novel mechanism of action in the treatment of depressive disorders. Clinical trials and interim results support significant reductions in depression scores for brexanolone in PPD, and for zuranolone in PPD, MDD, and BPD.
Publisher
Dove Medical Press Limited,Taylor & Francis Ltd,Dove,Dove Medical Press
Subject
/ Antidepressive Agents - administration & dosage
/ Antidepressive Agents - adverse effects
/ Antidepressive Agents - pharmacology
/ Anxiety
/ beta-Cyclodextrins - administration & dosage
/ beta-Cyclodextrins - adverse effects
/ beta-Cyclodextrins - pharmacology
/ bipolar
/ Bipolar Disorder - drug therapy
/ Bipolar Disorder - physiopathology
/ Depression, Postpartum - drug therapy
/ Depressive Disorder - drug therapy
/ Depressive Disorder - physiopathology
/ Female
/ Humans
/ Placebos
/ Pregnanes - administration & dosage
/ Pregnanolone - administration & dosage
/ Pregnanolone - adverse effects
/ Psychiatric Status Rating Scales
/ Pyrazoles - administration & dosage
/ Review
/ Safety
/ Therapy
/ Websites
