Plain-English translation of NCT03646058 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This study is testing whether , a medication used in pain management, might help reduce severe suicidal thoughts in people experiencing a major depressive episode. Researchers want to see if taking this medication for 21 days can make a meaningful difference in how intense these thoughts are, especially in the first week. You would be randomly assigned to receive either the medication at one of two doses or a placebo (inactive pill).
Depression with severe suicidal thoughts is a medical emergency, and current treatments don't help everyone quickly enough. This medication may work on parts of the brain involved in both pain and suicidal thinking, offering a potential new way to help people in crisis.
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You will take either the medication or a placebo pill by mouth once daily for 21 days, then taper off over one week. During the treatment period, researchers will closely monitor how your suicidal thoughts change, especially in the first week. You'll also have follow-up phone calls at 3 and 6 months to check on your wellbeing, and you may have blood or stool samples collected at certain visits for future research.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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