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The additive effect of ketamine in combination with electroconvulsive stimulation (ECS) in major depressive disorder (MDD): a translational study
EU CTIS ID: 2024-512559-20-01
What this study is testing
The primary objective of this study is to evaluate the antidepressant effect of ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant depression.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant is willing and able to give informed consent for participation in the study.
- Male and Female, aged 18-70.
- Women of childbearing potential (WOCBP) must use at least 1 highly effective method of contraception. Highly effective methods of contraception are those which have a failure rate of <1% (when implemented consistently and correctly) and include: Intrauterine device (IUD), Bilateral tubal ligation, bilateral salpingectomy, or bilateral tubal occlusive procedure, Hormonal contraceptives (eg, oral, patch, or injectable), A double-barrier protection method (eg, condom, sponge, or vaginal diaphragm with spermicide cream, foam, or gel); abstinence from heterosexual intercourse is accepted if this is the participant’s usual lifestyle.
- Diagnosed with major depressive disorder (according to SCID5-CV scale).
- Affected by treatment resistant depression (defined as at least 2 different antidepressant agents used without success).
- Adequacy of the score for anesthesia.
You likely can't join if
- Chronic neurological disease.
- 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 liver impairment, will also be excluded to prevent potential adverse events.
- 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),
- Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, implantable electronic devises, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurism, endocrine disorders, neuromuscular disease, space-occupying brain lesions, stroke in the last 6 months).
See the full eligibility criteria
Who can join
- Participant is willing and able to give informed consent for participation in the study.
- Male and Female, aged 18-70.
- Women of childbearing potential (WOCBP) must use at least 1 highly effective method of contraception. Highly effective methods of contraception are those which have a failure rate of <1% (when implemented consistently and correctly) and include: Intrauterine device (IUD), Bilateral tubal ligation, bilateral salpingectomy, or bilateral tubal occlusive procedure, Hormonal contraceptives (eg, oral, patch, or injectable), A double-barrier protection method (eg, condom, sponge, or vaginal diaphragm with spermicide cream, foam, or gel); abstinence from heterosexual intercourse is accepted if this is the participant’s usual lifestyle.
- Diagnosed with major depressive disorder (according to SCID5-CV scale).
- Affected by treatment resistant depression (defined as at least 2 different antidepressant agents used without success).
- Adequacy of the score for anesthesia.
What rules you out
- Chronic neurological disease.
- 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 liver impairment, will also be excluded to prevent potential adverse events.
- 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),
- Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, implantable electronic devises, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurism, endocrine disorders, neuromuscular disease, 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,
- Pregnancy and lactation
- Cardiovascular conditions
- Any other Psychiatric Disorders, other than MDD
- Hepatic impairment
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.