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

Major Depressive Disorder Clinical Trial

— TARGET  

Official title:

A Randomized, Active-Controlled, Evaluation of AXS-05 for the Treatment of Treatment Resistant Depression in Treatment-Adherent Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04971291
• Other study ID #: AXS-05-TRD-203
• Status: Enrolling by invitation
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder
• Treatment Resistant Depression

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