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

Overview

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.

Full Title of Study: “A Randomized, Active-Controlled, Evaluation of AXS-05 for the Treatment of Treatment Resistant Depression in Treatment-Adherent Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2021

Interventions

  • Drug: AXS-05
    • AXS-05 taken twice daily for 6 weeks
  • Drug: Bupropion SR
    • Bupropion taken twice daily for 6 weeks

Arms, Groups and Cohorts

  • Experimental: AXS-05
  • Active Comparator: Bupropion SR

Clinical Trial Outcome Measures

Primary Measures

  • Montgomery-├ůsberg Depression Rating Scale (MADRS) total score
    • Time Frame: Change from Baseline to Week 6
    • The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.

Participating in This Clinical Trial

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 prior ADTs – Body mass index (BMI) between 18 and 40 kg/m2, inclusive 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Axsome Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.