Assessing Symptomatic Clinical Episodes in Depression

Completed · Phase 2

Conditions studied: Major Depressive Disorder

In brief

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

Key facts

Study ID

NCT03595579

Run by

Axsome Therapeutics, Inc.

People needed

97

Starts

2018-05-30

Expected to finish

2019-01-07

Last updated by the study team

2021-09-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Currently meets DSM-5 criteria for MDD
• Body mass index (BMI) between 18 and 40 kg/m\^2, inclusive
• Agree to use adequate method of contraception for the duration of the study
• Additional criteria may apply

You may not qualify if…

• Suicide risk
• History of treatment resistance in current depressive episode
• History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
• Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
• Additional criteria may apply

Where it is running

• Clinical Research Site — Beverly Hills, California, United States
• Clinical Research Site — Jacksonville, Florida, United States
• Clinical Research Site — Orlando, Florida, United States
• Clinical Research Site — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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