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

Phase 2

• Conditions: Major Depressive Disorder; Treatment Resistant Depression
• Interventions: Drug: AXS-05; Drug: Bupropion SR

• Registration Number: NCT04971291
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-14
• Status Verified: 2021-07
• Primary Completion: 2021-07
• Study Completion: 2021-07
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-07-21
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 312

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXS-05	AXS-05	45 mg dextromethorphan-105 mg bupropion
Bupropion SR	Bupropion SR	150 mg bupropion

Primary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale (MADRS) total score	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.

Trial Locations

Locations (1)

Axsome Research Site; 🇺🇸 New York, New York, United States