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 range18 Years – 85 Years

SexALL

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

What they're measuring

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

Trial details

NCT IDNCT02659085

SponsorPouya Movahed Rad

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08