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

Primary Purpose

Major Depressive Disorder, Treatment Resistant Depression

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AXS-05
Bupropion SR
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring AXS-05, Axsome, NMDA receptor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Axsome Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AXS-05

Bupropion SR

Arm Description

45 mg dextromethorphan-105 mg bupropion

150 mg bupropion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2021
Last Updated
July 20, 2021
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04971291
Brief Title
An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients
Acronym
TARGET
Official Title
A Randomized, Active-Controlled, Evaluation of AXS-05 for the Treatment of Treatment Resistant Depression in Treatment-Adherent Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Treatment Resistant Depression
Keywords
AXS-05, Axsome, NMDA receptor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AXS-05
Arm Type
Experimental
Arm Description
45 mg dextromethorphan-105 mg bupropion
Arm Title
Bupropion SR
Arm Type
Active Comparator
Arm Description
150 mg bupropion
Intervention Type
Drug
Intervention Name(s)
AXS-05
Intervention Description
AXS-05 taken twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Bupropion SR
Intervention Description
Bupropion taken twice daily for 6 weeks
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Description
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.
Time Frame
Change from Baseline to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Axsome Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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