Overview
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
Status:
Completed
Completed
Trial end date:
2020-03-20
2020-03-20
Target enrollment:
0
0
Participant gender:
All
All
Summary
To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD). This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD. Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Axsome Therapeutics, Inc.Treatments:
Bupropion
Criteria
Key Inclusion Criteria:- Currently meets DSM-V criteria for MDD
- History of inadequate response to 1 or 2 adequate antidepressant treatments
- Body mass index (BMI) between 18 and 40 kg/m2, inclusive
- Agree to use adequate method of contraception for the duration of the study
- Additional criteria may apply
Key Exclusion Criteria:
- Suicide risk
- Treatment with any investigational drug within 6 months
- History of electroconvulsive therapy (ECT), 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