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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder Treatment Resistant Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AXS-05

45 mg dextromethorphan-105 mg bupropion

Group Type EXPERIMENTAL

AXS-05

Intervention Type DRUG

AXS-05 taken twice daily for 6 weeks

Bupropion SR

150 mg bupropion

Group Type ACTIVE_COMPARATOR

Bupropion SR

Intervention Type DRUG

Bupropion taken twice daily for 6 weeks

Interventions

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AXS-05

AXS-05 taken twice daily for 6 weeks

Intervention Type DRUG

Bupropion SR

Bupropion taken twice daily for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No