Phase 2
N=97
Assessing Symptomatic Clinical Episodes in Depression
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03595579 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: MADRS Score - Overall Change From Baseline — 13.7; 8.8 score on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AXS-05 (Drug); Bupropion (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Axsome Therapeutics, Inc.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MADRS Score - Overall Change From Baseline |
13.7; 8.8 | <.001 sig |
Summary
Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03595579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.