Ketamine as an Alternative Treatment to ECT in Major Depressive Disorder (NCT02659085) | Clinical Trial Compass
CompletedPhase 2/3
Ketamine as an Alternative Treatment to ECT in Major Depressive Disorder
Sweden198 participantsStarted 2015-02
Plain-language summary
Developing more effective and faster acting antidepressant is of outmost clinical importance. Available antidepressant therapies have a delayed therapeutic effect. It typically takes several weeks before symptom relief is evident. Furthermore, antidepressants are relatively ineffective - as many as 30% of patients do not respond to any medication at all. In this study the investigators evaluate the NMDA-receptor antagonist ketamine as a potentially new antidepressant treatment for severely depressed patients and compare its effectiveness with that of electroconvulsive therapy (ECT).
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18-85
* Diagnosed with major depressive disorder (MDD, according to DSM-IV)
* Inpatients who have been offered and have accepted ECT
* Are eligible to participate
* Score ≥ 20 Points on Montgomery Åsberg Depression Rating Scale (MADRS)
* Must be proficient in spoken and written Swedish
* American Society of Anaesthesiologists physical status classification (ASA) 1-3
Exclusion Criteria:
* Co-morbid conditions that could interfere with the treatment (e.g. primary psychosis)
* Habitual difficulties to speak, hear, remember or reason
* Treatment according to LPT (Lagen om psykiatrisk tvångsvård; Compulsory Psychiatric Care Act)
* On-going or recent (6 months) drug abuse
* Known allergy to the active substance
* Pregnant or breastfeeding women
* Known cardiovascular disease, including angina, acute/chronic congestive heart failure, moderly hypertension or tachyarrhythmia (because exacerbation by sympathomimetic properties of ketamine)
* Pathological conditions in central nervous system with risk of increased intracranial pressure (increased ICP with ketamine)
* Glaucoma (increased IOP with ketamine)
* Porphyria or thyroid disorder (enhanced sympathomimetic properties by ketamine)
* Ongoing severe infection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients in remission in each treatment arm assessed by Montgomery-Asberg Depression Rating Scale (MADRS)
Timeframe: Follow up of one year after treatment cessation