Ketamine Augmentation of ECT in Treatment-Resistant Depression
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversità Vita-Salute San Raffaele
About this trial
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 criteria
Qualifiers
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,
Disqualifiers
Chronic neurological diseases,
Intellectual disability
Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurysm, endocrine disorders, neuromuscular diseases, space occupying brain lesions, stroke in the last 6 months),
Patients with Alcohol Use Disorder or Substance Use Disorder or Substance Abuse history in the past year,
Trial design
Treatments tested in this trial
- Ketamine Hydrochloride
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov