zuranolone: Clinical Trials

13 completed, 2 recruiting, 2 terminated. 8 Phase 3, 5 Phase 2, 2 Phase 1.

By phase and status

Phase	Trials	Status
Phase 3	8	Completed 6, Terminated 2
Phase 2	5	Completed 4, Recruiting 1
Phase 1	2	Completed 2

Follow zuranolone: new trials by email Literature Review of zuranolone trials Research Report on zuranolone

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Allopregnanolone (Zuranolone) in Post-stroke Depression Zuranolone - Post Stroke Depression	Phase 2	Recruiting	Duke University	6	2026-01-30	2026-09-03
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone Zuranolone - Postpartum Depression		Recruiting	Biogen	300	2025-12-22	2026-09-08
A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy Zuranolone - Depression, Postpartum		Completed	Biogen	305	2025-06-30	2026-09-08
Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD) Zuranolone - Major Depressive Disorder	Phase 1	Completed	Biogen	19	2023-04-19	2025-03-26
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder SAGE-217, Matching Placebo, Sertraline - Depressive Disorder, Major	Phase 3	Completed	Biogen	440	2020-11-09	2023-12-22
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD) SAGE-217, Placebo - Depression, Postpartum	Phase 3	Completed	Biogen	200	2020-06-08	2023-11-30
A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD) SAGE-217, Placebo - Depressive Disorder, Major	Phase 3	Completed	Biogen	543	2020-05-12	2023-12-22
A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder SAGE-217, Placebo - Major Depressive Disorder	Phase 3	Terminated	Biogen	53	2019-08-06	2023-11-29
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD) SAGE-217 - Major Depressive Disorder	Phase 3	Completed	Biogen	1515	2019-02-27	2024-08-27
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 SAGE-217, Placebo - Major Depressive Disorder, Insomnia	Phase 3	Terminated	Biogen	87	2019-02-04	2023-11-29
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder SAGE-217, Placebo - Major Depressive Disorder	Phase 3	Completed	Biogen	581	2018-11-19	2023-11-29
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode SAGE-217, Placebo - Bipolar Disorder I, Bipolar Disorder II	Phase 2	Completed	Biogen	35	2018-08-23	2023-12-13
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model SAGE-217 high dose, Placebo, SAGE-217 low dose - Healthy	Phase 1	Completed	Biogen	45	2017-09-14	2023-11-29
A Study to Evaluate SAGE-217 in Participants With Essential Tremor SAGE-217, Placebo - Essential Tremor	Phase 2	Completed	Biogen	34	2017-03-24	2023-11-28
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression SAGE-217 15/20 mg Oral Solution, Placebo, SAGE 217 30 mg Capsules - Postpartum Depression	Phase 3	Completed	Biogen	276	2017-01-04	2023-12-15
A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder SAGE-217, Placebo - Major Depression	Phase 2	Completed	Biogen	102	2016-12-07	2023-11-28
A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease SAGE-217, Levodopa, Antiparkinsonian Agent(s) - Parkinson Disease	Phase 2	Completed	Biogen	29	2016-11-30	2023-11-29

Conditions studied

Depressive Disorder, Major (8)  ·  Depression, Postpartum (4)  ·  Depression (3)  ·  Bipolar Disorder (1)  ·  Depressive Disorder (1)  ·  Essential Tremor (1)  ·  Parkinson Disease (1)  ·  Sleep Initiation and Maintenance Disorders (1)  ·  Stroke (1)  ·  Tremor (1)

Sponsors

Biogen (16)  ·  Duke University (1)

Countries

United States (17)  ·  Spain (1)  ·  United Kingdom (1)

Top investigators

Nada El Husseini, MD (1)

Results publications

PMID 34190962, PMID 35378149, PMID 36724109, PMID 36811520, PMID 37491938, PMID 37875578, PMID 38153320

NIH funding

2019 (1)