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New treatment option for Major Depressive Disorder
Official title Ketamine Augmentation of ECT in Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT07088380
What this study is testing
What is Ketamine Hydrochloride?
Ketamine Hydrochloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Male and female people 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.
You likely can't join if
- Chronic neurological diseases,
- Intellectual disability
- Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, uncontrolled hypertension...
- Patients with Alcohol Use Disorder or Substance Use Disorder or Substance Abuse history in the past year,
- Pregnancy and lactation
- Cardiovascular conditions,
See the full eligibility criteria
- Male and female people 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.
- 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...
- Patients with Alcohol Use Disorder or Substance Use Disorder or Substance Abuse history in the past year,
- Pregnancy and lactation
- Cardiovascular conditions,
- Psychiatric Disorders,
- Hepatic impairment,
- Participants with a known hypersensitivity to ketamine or any of its excipients will be excluded from the study,
- Participants with any contraindications to the use of ketamine, such as a history of severe cardiovascular conditions (e.g., uncontrolled hypertension, significant arrhythmias), intracranial hypertension, or severe...
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.