SAGE-217

DRUG11 trials

Sponsors

Biogen

Conditions

Bipolar Disorder IBipolar Disorder IIDepression, PostpartumDepressive Disorder, MajorEssential TremorInsomniaMajor DepressionMajor Depressive Disorder

Phase 2

A Study to Evaluate SAGE-217 in Participants With Essential Tremor

CompletedNCT02978781

BiogenEssential Tremor

Start: 2017-03-24End: 2017-12-05Updated: 2023-11-28

A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder

CompletedNCT03000530

BiogenMajor Depression

Start: 2016-12-07End: 2017-11-08Updated: 2023-11-28

A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease

CompletedNCT03000569

BiogenParkinson Disease

Start: 2016-11-30End: 2017-09-11Updated: 2023-11-29

A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode

CompletedNCT03692910

BiogenBipolar Disorder I, Bipolar Disorder II, Major Depressive Episode

Start: 2018-08-23End: 2019-05-21Updated: 2023-12-13

Phase 3

A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder

CompletedNCT03672175

BiogenMajor Depressive Disorder

Start: 2018-11-19End: 2020-03-17Updated: 2023-11-29

A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia

TerminatedNCT03771664

BiogenInsomnia, Major Depressive Disorder

Start: 2019-02-04End: 2020-01-17Updated: 2023-11-29

A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)

CompletedNCT03864614

BiogenMajor Depressive Disorder

Start: 2019-02-27End: 2023-06-22Updated: 2024-08-27

A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder

TerminatedNCT04007367

BiogenMajor Depressive Disorder

Start: 2019-08-06End: 2020-01-06Updated: 2023-11-29

A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

CompletedNCT04442503

BiogenDepression, Postpartum

Start: 2020-06-08End: 2022-04-12Updated: 2023-11-30

A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)

CompletedNCT04442490

BiogenDepressive Disorder, Major

Start: 2020-05-12End: 2021-04-21Updated: 2023-12-22

A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

CompletedNCT04476030

BiogenDepressive Disorder, Major

Start: 2020-11-09End: 2021-12-22Updated: 2023-12-22

Related Papers

Zuranolone Safety and Tolerability in Adults with Postpartum Depression: Analyses from SKYLARK, a 50 mg Placebo-Controlled Study

CNS Spectrums2024-10-01

Zuranolone: A Narrative Review of a New Oral Treatment for Postpartum Depression.

2024-05-013 citations

Indirect comparisons of relative efficacy estimates of zuranolone and selective serotonin reuptake inhibitors for postpartum depression.

2024-01-018 citations

Long-Term Safety and Efficacy of Initial and Repeat Treatment Courses With Zuranolone in Adult Patients With Major Depressive Disorder

The Journal of Clinical Psychiatry2023-12-2112 citations

Efficacy and safety of zuranolone co-initiated with an antidepressant in adults with major depressive disorder: results from the phase 3 CORAL study.

2023-10-2419 citations

Improvement in HAMD-17 Subscale Scores With 14-Day Treatment Course of Zuranolone in Postpartum Depression: Results From the SKYLARK Study [ID: 1372313]

Obstetrics and Gynecology2023-05-011 citations

Zuranolone in Major Depressive Disorder

The Journal of Clinical Psychiatry2023-02-1760 citations

Overview of the Rapid Antidepressant Effects Observed in the Zuranolone Clinical Development Program [A164]

Obstetrics and Gynecology2022-05-013 citations

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

Journal of Affective Disorders2022-04-0222 citations

Effect of Zuranolone vs Placebo in Postpartum Depression

JAMA Psychiatry2021-06-30233 citations

0535 Evaluation of Insomnia Symptoms in a Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial of Sage-217 in Postpartum Depression

SLEEP2020-04-01

A Phase 3, double-blind, placebo-controlled trial of SAGE-217 in postpartum depression: Assessment of depressive symptoms across multiple measures

Pharmacopsychiatry2020-02-242 citations

Trial of SAGE-217 in Patients with Major Depressive Disorder

New England Journal of Medicine2019-09-04223 citations