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NMDA receptor antagonist

AXS-05 for Major Depressive Disorder (TARGET Trial)

Phase 2
Waitlist Available
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to week 6
Awards & highlights

TARGET Trial Summary

The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug. Subjects are considered to have treatment-resistant MDD if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments (ADTs) and a prospective inadequate response to treatment with bupropion SR, during the current major depressive episode. The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan (in the AXS-05 group) and bupropion (in the bupropion group), and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent. Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301.

Eligible Conditions
  • Depression
  • Major Depressive Disorder

TARGET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Side effects data

From 2019 Phase 3 trial • 327 Patients • NCT04019704
29%
All Others, occurring in <5% of Subjects
16%
Dizziness
13%
Nausea
8%
Headache
7%
Somnolence
7%
Diarrhea
6%
Dry mouth
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AXS-05

TARGET Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AXS-05Experimental Treatment1 Intervention
45 mg dextromethorphan-105 mg bupropion
Group II: Bupropion SRActive Control1 Intervention
150 mg bupropion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXS-05
2018
Completed Phase 3
~1390

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
28 Previous Clinical Trials
7,880 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients
2021. "An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04971291.
All > Wellbutrin
~78 spots leftby May 2025
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