NCT03595579

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2 major-depressive-disorder

Timeline
Completed

Started May 2018

Shorter than P25 for phase_2 major-depressive-disorder

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 24, 2021

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

June 20, 2018

Results QC Date

July 30, 2021

Last Update Submit

September 22, 2021

Conditions

Major Depressive Disorder

Keywords

AXS-05Major Depressive DisorderMDDAxsomeDepressionDextromethorphanBupropionSigma-1NDMAASCEND

Outcome Measures

Primary Outcomes (1)

  • MADRS Score - Overall Change From Baseline

    The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Ã…sberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.

    Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)

Other Outcomes (1)

  • MADRS Score - Change From Baseline to Week 6

    6 weeks

Study Arms (2)

AXS-05

EXPERIMENTAL
Drug: AXS-05

Bupropion

ACTIVE COMPARATOR
Drug: Bupropion

Interventions

AXS-05DRUG

AXS-05 taken twice daily for 6 weeks.

AXS-05
BupropionDRUG

Bupropion taken twice daily for 6 weeks.

Bupropion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinical Research Site

Beverly Hills, California, 90210, United States

Location

Clinical Research Site

Jacksonville, Florida, 32256, United States

Location

Clinical Research Site

Orlando, Florida, 32801, United States

Location

Clinical Research Site

Bellevue, Washington, 98007, United States

Location

Related Publications (1)

  • Tabuteau H, Jones A, Anderson A, Jacobson M, Iosifescu DV. Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial. Am J Psychiatry. 2022 Jul;179(7):490-499. doi: 10.1176/appi.ajp.21080800. Epub 2022 May 18.

    PMID: 35582785DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Amanda Jones, PharmD, Senior Vice President of Clinical Development
Organization
Axsome Therapeutics, Inc.
ajones@axsome.com
212-332-3223

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 23, 2018

Study Start

May 30, 2018

Primary Completion

January 7, 2019

Study Completion

January 7, 2019

Last Updated

September 24, 2021

Results First Posted

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

via publication

Locations

US(4)