An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients

Last updated: July 20, 2021
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Active - Enrolling

Phase

2

Condition

Depression (Adult And Geriatric)

Mood Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT04971291
AXS-05-TRD-203
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Provided written informed consent to participate in Study AXS-05-301
  • Has treatment-resistant depression, defined as an inadequate response to 2 or 3 priorADTs
  • Body mass index (BMI) between 18 and 40 kg/m2, inclusive

Exclusion

Key Exclusion Criteria:

  • Suicide risk
  • Treatment with any investigational drug within 6 months
  • History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranialmagnetic stimulation, or any experimental central nervous system treatment during thecurrent episode or in the past 6 months
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Study Design

Total Participants: 312
Study Start date:
April 14, 2021
Estimated Completion Date:
July 31, 2021

Connect with a study center

  • Axsome Research Site

    New York, New York 10007
    United States

    Site Not Available

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