Clinical TrialTreatment-Resistant Depression (TRD)EsketamineWithdrawn

ECT vs. Esketamine

This longitudinal, randomized controlled trial (n=0, withdrawn) compares the efficacy of Electroconvulsive Therapy (ECT) and intranasal esketamine in patients with Treatment-Resistant Depression (TRD).

Target Enrollment
Not specified
Study Type
Phase III interventional
Design
Randomized

Detailed Description

Randomised, parallel-group trial comparing intranasal esketamine (twice weekly, up to 8 sessions) versus ECT (three times weekly, up to 12 sessions) in inpatients with treatment-resistant depression at Medical University Innsbruck.

Primary aims include effectiveness for depressive symptoms and effects on brain connectivity and structure assessed by functional MRI; treatment period is up to 4 weeks with imaging and clinical follow-up.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Esketamine

experimental

Intranasal esketamine administered twice weekly for up to 4 weeks (max 8 sessions) or until remission (MADRS <10).

Interventions

  • Esketamine
    via Other• twice weekly• 8 doses total

    Up to 8 intranasal esketamine sessions over 4 weeks or until MADRS <10.

ECT

active comparator

Electroconvulsive therapy administered thrice weekly for up to 4 weeks (max 12 sessions) or until remission (MADRS <10).

Interventions

  • Compound
    via Other• three times weekly• 12 doses total

    Up to 12 ECT treatments over 4 weeks or until MADRS <10.

Participants

Ages
18 – 50
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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 exclusion criteria for nasal esketamine treatment as described in the clinical guidelines
  • 4. Contraindications to the conduction of MRI
  • 5. History of one or more of the following diagnoses (DSM-5):
  • * MDD, single or recurrent episode with psychotic features (296.24; 296.34)
  • * past or current substance dependence (except caffeine, nicotine) (303.x, 304.x, 305.x)
  • * neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x)
  • * schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x)
  • * neurocognitive disorders (290.x, 292.x, 294.x, 331.x).
  • 6. history of ECT (unsuccessful or successful)
  • 7. suicidal tendency requiring admission in a locked ward
  • 8. pregnancy or lactation period
  • 9. lack of anesthetic clearance for any other reason
  • 10. insufficient command of German language.

Study Details

Locations

Medical University Innsbruck — Innsbruck, Tyrol, Austria

Your Library