Major Depressive Disorder, Treatment Resistant Depression
Conditions
Keywords
AXS-05, Treatment Resistant Depression, TRD, NMDA receptor, Refractory depression, Resistant depression, Depression, Major depression, Relapse prevention, Dextromethorphan, Bupropion
Brief summary
To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD). This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.
Interventions
DRUGAXS-05
AXS-05 taken daily for up to 52 weeks, until relapse.
DRUGPlacebo
Placebo taken daily for up to 52 weeks, until relapse.
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Eligibility Criteria: * Ongoing symptoms of depression despite receiving treatment with two or more prior antidepressants during the current major depressive episode, prior to receiving AXS-05 * Agree to use adequate method of contraception for the duration of the study * Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse | Time from randomization to first relapse (up to 52 weeks) | Assessed by clinician-rated scales. |
Countries
United States
Outcome results
None listed