Adults 18 to 65, any sex, with Depressive Disorder, Major. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total ScorePrimary· Baseline and 1 Day
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Group
Value
95% CI
Placebo
-17.6
± 12.49
Rapastinel 450mg
-16.3
± 11.36
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total ScorePrimary· Baseline and 1 Day
The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.
Group
Value
95% CI
Placebo
-20.6
± 12.27
Rapastinel 450mg
-20.2
± 11.93
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total ScoreSecondary· Baseline and 28 Days
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Group
Value
95% CI
Placebo
-25.6
± 14.74
Rapastinel 450mg
-23.0
± 15.00
Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total ScoreSecondary· Baseline and 28 Days
The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.
Group
Value
95% CI
Placebo
-25.9
± 11.61
Rapastinel 450mg
-26.4
± 12.74
Adverse events — posted to ClinicalTrials.gov
Time frame: The study consisted of a 4 week double-blind treatment period, followed by a 1-week safety follow-up period..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Naurex, Inc, an affiliate of Allergan plc
Last refreshed: 14 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03352453.