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

NCT04971291 | Unknown Phase 2 FDA Drug

• 1 other identifier: AXS-05-TRD-203
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Treatment Resistant Depression

Keywords

AXS-05; Axsome; NMDA receptor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

AXS-05

EXPERIMENTAL

45 mg dextromethorphan-105 mg bupropion

Drug: AXS-05

Bupropion SR

ACTIVE COMPARATOR

150 mg bupropion

Drug: Bupropion SR

Interventions

AXS-05 DRUG

AXS-05 taken twice daily for 6 weeks

AXS-05

Bupropion SR DRUG

Bupropion taken twice daily for 6 weeks

Bupropion SR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Axsome Therapeutics, Inc.: lead

Study Sites (1)

Axsome Research Site

New York, New York, 10007, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: April 14, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)