Non-psychotic therapy resistant unipolar depression
Conditions
Brief summary
The primary objective of this trial is to compare the shortterm efficacy of oral esketamine versus ECT in patients with NTRD. In this regard, the percentage of treatment response, defined as a ≥30% reduction on the MADRS, in the esketamine relative to the ECT condition after eight weeks of treatment will be determined. Non-inferiority is defined as the esketamine arm having no less than 70% of the efficacy of ECT., In this regard, the percentage of relapse, defined as a <30% reduction, in the esketamine relative to the ECT condition after 12 months of maintenance treatment will be determined.
Interventions
DRUGKetanest-S 25 Multi-dose
DRUGoplossing voor injectie 25 mg/ml
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this trial is to compare the shortterm efficacy of oral esketamine versus ECT in patients with NTRD. In this regard, the percentage of treatment response, defined as a ≥30% reduction on the MADRS, in the esketamine relative to the ECT condition after eight weeks of treatment will be determined. Non-inferiority is defined as the esketamine arm having no less than 70% of the efficacy of ECT., In this regard, the percentage of relapse, defined as a <30% reduction, in the esketamine relative to the ECT condition after 12 months of maintenance treatment will be determined. | — |
Countries
Netherlands
Outcome results
None listed