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Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 12, 2025 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Jun 1, 2025 to Jun 1, 2026 Eligibility criteria expanded, about 452 words · Site contact updatedv3 Show 2 more changesShow less
    • Eligibility criteria expanded, about 452 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Aug 1, 2022 to Oct 13, 2022 · Eligibility criteria expanded, about 17 wordsv2 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 1, 2022 to Oct 13, 2022
    • Eligibility criteria expanded, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.
Trial Details
NCT Number NCT05450432
Lead Sponsor Massachusetts General Hospital
Collaborators: American Foundation for Suicide Prevention
Conditions Major Depressive Disorder
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov