The Additive Effect of Ketamine in Combination With ElectroConvulsive Stimulation (ECS) in Major Depressive Disorder (MDD): a Translational Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Male and female subjects ages 18-70,
• diagnosed with MDD (according to SCID5-CV interview)
• treatment resistant (defined as at least 2 different antidepressant agents used without success),
• ability to give informed consent,
• adequacy of the score for anesthesia.
Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele Turro
RECRUITING
Milan
Contact Information
Primary
Alberto AZ Zangrillo, MD
zangrillo.alberto@hsr.it
0226436154
Backup
Cristina CC Colombo, MD
colombo.cristina@hsr.it
0226435278
Time Frame
Start Date:2025-07-10
Estimated Completion Date:2026-02
Participants
Target number of participants:30
Treatments
Experimental: Ketamine
Patients receive standard ECT treatment combined with intravenous ketamine at a subanesthetic dose of 0.5 mg/kg, administered after induction with Propofol. Ketamine is administered during ECT sessions 2, 4, and 6.~Intervention:~* Drug: Ketamine~* Dose: 0.5 mg/kg IV~* Timing: ECT sessions 2, 4, and 6~* Background: Investigating the additive antidepressant and potential cognitive-protective effects of ketamine in patients with treatment-resistant depression undergoing ECT.
Placebo_comparator: Placebo
Patients receive standard ECT treatment combined with placebo (0.9% sodium chloride solution), administered intravenously after induction with Propofol, during ECT sessions 2, 4, and 6, mimicking the ketamine group's schedule.~Intervention:~* Drug: Saline solution (NaCl 0.9%)~* Timing: ECT sessions 2, 4, and 6~* Background: Serves as control to assess the specific contribution of ketamine to antidepressant efficacy and cognitive outcomes.