This study focuses on patients with non-psychotic therapy resistant unipolar depression, a severe form of depression that has not improved with standard treatments. The research compares two different treatments: oral esketamine (a medication) and Electroconvulsive Therapy (ECT). The purpose is to determine if oral esketamine works as effectively as ECT in treating this type of depression.
The study is divided into two phases. In the first phase, lasting eight weeks, patients receive either oral esketamine or ECT treatment. The second phase extends for one year and examines how well these treatments prevent the depression from returning in patients who showed improvement during the first phase.
During the treatment period, patients initially receive care in a hospital setting and then continue their treatment as outpatients. The medication being tested, esketamine, is a modified version of an existing injectable solution that has been adapted for oral use by adding ingredients to make it suitable for taking by mouth. The maximum daily dose of esketamine is 3.0 mg per kilogram of body weight, and treatment can continue for up to 60 days.



The Netherlands