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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04971291
Other study ID # AXS-05-TRD-203
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date April 14, 2021
Est. completion date July 2021

Study information

Verified date July 2021
Source Axsome Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 312
Est. completion date July 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Axsome Research Site New York New York

Sponsors (1)

Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montgomery-Åsberg Depression Rating Scale (MADRS) total score 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. Change from Baseline to Week 6
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