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CompletedPhase 2 / Phase 3

Ketamine as an Alternative Treatment to ECT in Major Depressive Disorder

NCT02659085 · Pouya Movahed Rad

Closed to entry
Status
Not accepting participants
Phase 2 / Phase 3
Phase
198
Target enrolment
1
Study sites
Outside the US

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Proportion of patients in remission in each treatment arm assessed by Montgomery-Asberg Depression Rating Scale (MADRS)

    Measured over Follow up of one year after treatment cessation

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 85 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Department of PsychiatryLund—Sweden

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02659085 on ClinicalTrials.gov →

Last updated in the registry 2019-12-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance