Ketamine Augmentation of ECT in Treatment-Resistant Depression
Recruiting
Phase 3
Interventional Study
Major Depressive Disorder
Treatment Resistant Depression
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Università Vita-Salute San Raffaele · Other
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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 ho…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusio…
Contacts