Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboRecruiting

Ketamine Augmentation of ECT in Treatment-Resistant Depression (Ketamina)

Phase III double-blind, randomised, placebo-controlled trial (n=30) testing IV ketamine 0.5 mg/kg given during ECT sessions 2, 4 and 6 in hospitalised adults with treatment-resistant MDD.

Target Enrollment
30 participants
Study Type
Phase III interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, placebo-controlled Phase III trial assessing whether adjunctive IV ketamine enhances antidepressant response to ECT in treatment‑resistant major depressive disorder. Thirty participants will receive ketamine or saline during ECT sessions 2, 4 and 6.

Primary outcome is change in MADRS at 4 weeks; secondary outcomes include cognitive side effects and safety measures. Ketamine is given at a subanesthetic dose (0.5 mg/kg IV) after induction with Propofol to evaluate additive antidepressant and potential cognitive‑protective effects.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Standard ECT plus intravenous ketamine (subanesthetic) given during ECT sessions 2, 4 and 6.

Interventions

  • Ketamine0.5 mg/kg
    via IV• three sessions• 3 doses total

    0.5 mg/kg IV given after induction with Propofol during ECT sessions 2, 4 and 6.

Placebo

inactive

Standard ECT plus IV placebo (saline) administered to mimic ketamine schedule during ECT sessions 2, 4 and 6.

Interventions

  • Placebo
    via IV• three sessions• 3 doses total

    0.9% saline IV administered after induction with Propofol to match ketamine timing.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n\n* Male and female subjects aged 18–70 years\n* Diagnosis of major depressive disorder (SCID-5-CV)\n* Treatment resistant (≥2 different antidepressant agents without success)\n* Capacity to give informed consent\n* Adequacy for anaesthesia assessment

Exclusion Criteria

  • Exclusion Criteria:\n\n* Chronic neurological diseases or intellectual disability\n* Contraindications to electroconvulsive therapy (e.g., severe aortic stenosis, implantable cardiac defibrillator, uncontrolled hypertension, recent stroke, space-occupying brain lesion)\n* Alcohol use disorder, substance use disorder, or substance abuse in the past year\n* Pregnancy or lactation\n* Significant cardiovascular, respiratory, renal, hepatic, endocrine or neuromuscular disease\n* Known hypersensitivity to ketamine or excipients\n* Any contraindication to ketamine (e.g., uncontrolled hypertension, significant arrhythmias, intracranial hypertension, severe liver impairment)\n* Other significant psychiatric disorders as determined by investigator

Study Details

Locations

IRCCS Ospedale San Raffaele Turro — Milan, Italy

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