Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07088380 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Ketamine Augmentation of ECT in Treatment-Resistant Depression

Study acronym: Ketamina
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 11, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Feb 2026 to Aug 2026
    • Study completion date: Feb 2026 to Sep 2026
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2025 to Jul 10, 2025
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a randomized, double-blind, placebo-controlled phase 3 clinical trial evaluating the additive effect of intravenous ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant major depressive disorder (MDD). The study aims to determine whether ketamine enhances the antidepressant efficacy of ECT and reduces associated cognitive side effects. Thirty hospitalized patients diagnosed with treatment-resistant MDD will be randomized to receive either ketamine or placebo (saline) during ECT sessions 2, 4, and 6. Primary outcome is the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 weeks.
Trial Details
NCT Number NCT07088380
Lead Sponsor Università Vita-Salute San Raffaele
Conditions
(from sponsor)		 Major Depressive Disorder, Treatment Resistant Depression
Related terms Depression, Depressive Disorder, Treatment-Resistant, Major Depressive Disorder
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov