Assessing Symptomatic Clinical Episodes in Depression

• Status: Completed
• Trial end date: 2019-01-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axsome Therapeutics, Inc.
• Treatments: Bupropion

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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