A Phase 2 interventional study of AXS-05 and Placebo in Treatment Resistant Depression and Major Depressive Disorder, sponsored by Axsome Therapeutics, Inc.. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by Axsome Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 44 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Axsome Therapeutics, Inc. is the lead sponsor of 36 studies on the registry; 12 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 11 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Eligibility Criteria:
Drug: AXS-05
Drug: Placebo
AXS-05 taken daily for up to 52 weeks, until relapse.
Placebo taken daily for up to 52 weeks, until relapse.
Relapse
Assessed by clinician-rated scales.
Time frame: Time from randomization to first relapse (up to 52 weeks)
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Axsome Therapeutics, Inc.