Treatment Resistant Depression, Major Depressive Disorder
Conditions
Brief summary
Treatment-resistant depression (TRD) is a common cause of disability and one of the most common psychiatric disorders worldwide. Electroconvulsive therapy (ECT) is currently the most effective treatment for TRD. Recent developments showed esketamine to be a rapid-acting and effective antidepressant drug and it has been hailed as a breakthrough in treating TRD. Common treatment algorithms for TRD list ECT as a treatment option, but esketamine has not yet found its exact position in those algorithms. To the investigators' knowledge, a longitudinal, randomized controlled trial comparing the efficacy of ECT and intranasal esketamine in TRD patients has not been conducted. Furthermore, the investigators intend to measure effects of ECT and intranasal esketamine on brain connectivity and structure, using functional magnetic resonance imaging (fMRI). In this study, inpatients with TRD at the University Hospital for Psychiatry I, Medical University Innsbruck, will be randomized to ECT or intranasal esketamine. Short- and medium-term treatment effects on functional and structural connectivity in the brain will be determined using fMRI.
Interventions
Patients will receive two treatments per week for four weeks (maximum of eight treatment sessions) or until clinical remission (MADRS \<10).
PROCEDUREElectroconvulsive therapy
Patients will receive three treatments per week for four weeks (maximum of 12 ECT treatments) or until clinical remission (MADRS \<10).
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. DSM-5 diagnosis of Major Depressive Disorder (MDD) without psychotic features (296.22, 296.23, 296.32, 296.33) made through the Structured Clinical Interview for the DSM-V (SCID-V). 2. MADRS score ≥ 25 3. Pharmacologically treatment-resistant depressive episode \[Stage ≥ II, defined by Thase & Rush (1997): failure of at least 2 adequate trials of at least 2 distinctly different classes of antidepressants (≥ 4 weeks each)\] (88). 4. Age: 18 - 50 years 5. Written informed consent
Exclusion criteria
1. Participation in another interventional clinical trial 2. Relative contraindications to ECT treatment in accordance with the consensus paper of the Austrian Society of Psychiatry and Psychotherapy: 3. Patients who meet any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MADRS score | 4 weeks | Reduction of Montgomery-Asberg Depression Rating Scale (MADRS, 0-60 pts.); higher score indicates more depressive symptoms; response to treatment is defined as \>50% reduction in score |
Countries
Austria
Outcome results
None listed