Handan Gunduz-Bruce, MD, MBA

Open-Label, Phase 2 Trial of the Oral Neuroactive Steroid GABAA Receptor Positive Allosteric Modulator Zuranolone in Bipolar Disorder I and II

Background: Bipolar disorder (BPD) is a chronic, episodic illness affecting nearly 50 million globally, with disability mostly due to depressive episodes (MDEs). Zuranolone is an investig...

Handan Gunduz-Bruce , MD, MBA;

Abdul Sankoh , PhD;

Jeffrey Jonas , MD;

Indrani Nandy , PhD;

James Doherty , PhD;

Stephen Kanes , MD, PhD;

Robert Lasser , MD, MBA;

10/08/2020

Onset of Reduction in Depressive Symptoms in Postpartum Depression (PPD): Pivotal Studies of Two Neuroactive Steroid GABAA Receptor Positive Allosteric Modulators, Brexanolone Injection and Zuranolone

Background: Brexanolone injection (BRX) and the investigational compound, zuranolone (SAGE-217; ZRN), two neuroactive steroid (NAS) GABAA receptor positive allosteric modulators, were eva...

Samantha Meltzer-Brody , MD;

Handan Gunduz-Bruce , MD, MBA;

Helen Colquhoun , MD;

Kristina Deligiannidis , MD;

Stephen Kanes , MD, PhD;

10/08/2020

Edinburgh Postnatal Depression Scale (EPDS) Total Score Remission and Number Needed to Treat (NNT) Outcomes in a Phase 3, Placebo-Controlled Trial of Zuranolone in Postpartum Depression (PPD)

Background: Zuranolone (SAGE-217) is an investigational, neuroactive steroid and GABAA receptor positive allosteric modulator evaluated in a Phase 3 trial in patients with PPD (NCT0297832...

Kristina Deligiannidis , MD;

Ellison Suthoff , MBA, BS ;

Stephen Kanes , MD, PhD;

Brian Werneburg , PhD;

Ming-Yi Huang , PhD;

Robert Lasser , MD, MBA;

Vijayveer Bonthapally , PhD;

Handan Gunduz-Bruce , MD, MBA;

Sarah Acaster , MSc;

Moshe Fridman , PhD;

10/08/2020

Correlation of HAMD-17 and EPDS Scores in a Phase 3 Trial of Zuranolone: An Oral GABAA Receptor Positive Allosteric Modulator in Postpartum Depression

Background: PPD is a common medical complication during and after pregnancy. Zuranolone (SAGE-217) is an investigational neuroactive steroid and GABAA receptor positive allosteric modulat...

Kristina Deligiannidis , MD;

Stephen Kanes , MD, PhD;

Ming-Yi Huang , PhD;

Robert Lasser , MD, MBA;

Handan Gunduz-Bruce , MD, MBA;

Sarah Acaster , MSc;

Moshe Fridman , PhD;

Ellison Suthoff , MBA, BS ;

Vijayveer Bonthapally , PhD;

Abdul Sankoh , PhD;

Brian Werneburg , PhD;

Sigui Li , MS;