Major Depressive Disorder, Treatment Resistant Depression
Conditions
Keywords
AXS-05, Axsome, NMDA receptor
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.
Interventions
DRUGAXS-05
AXS-05 taken twice daily for 6 weeks
DRUGBupropion SR
Bupropion taken twice daily for 6 weeks
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed