Clinical TrialTreatment-Resistant Depression (TRD)EsketamineEsketamineUnknown status

Add-on Therapy With Edupression.Com® on Therapy Resistant Depressive Patients Treated With Nasal Esketamine Spray

This randomized, controlled pragmatic trial (n=70) assesses the value of adding edupression.com® as a therapy adjunct to esketamine nasal spray in therapy-resistant depressive (TRD) patients.

Target Enrollment
70 participants
Study Type
Phase NA interventional
Design
Randomized, single Blind

Detailed Description

Pragmatic randomised parallel-group trial (n=70) comparing treatment-as-usual with esketamine nasal spray plus access to edupression.com® versus esketamine alone in patients with therapy-resistant depression.

Edupression.com® is a licensed, CBT-based digital self-help program (psychoeducation, CBT elements and mood tracking). The study evaluates whether adding this low-intensity psychosocial intervention to esketamine treatment improves clinical outcomes in TRD.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

edupression + TAU

experimental

edupression.com® plus treatment-as-usual esketamine nasal spray

Interventions

  • Compound
    via Other• continuous access

    edupression.com® digital CBT-based self-help program; full access during study

  • Esketamine
    via Other• per clinical care

    Esketamine nasal spray (Spravato®) as treatment-as-usual; dose per local label and clinical care

TAU

active comparator

Treatment-as-usual with esketamine nasal spray

Interventions

  • Esketamine
    via Other• per clinical care

    Esketamine nasal spray (Spravato®) as treatment-as-usual

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age 18 or older
  • Initial MADRS-Score of 22 or above
  • Diagnosis of a therapy-resistant depression following the definition of the European Medicines Agency (EMA) - absence of remission after two or more guideline-oriented therapies
  • Patients assigned to treatment with nasal esketamine spray Spravato®
  • Signed informed consent
  • Native German speaker
  • Basic knowledge in using computers/smartphones operationalized as daily use of at least two devices (such as tablets, computers, smartphones etc)

Exclusion Criteria

  • Exclusion Criteria:
  • Contraindication regarding the use of Spravato®
  • Diagnosis of one of the following psychiatric comorbidities: substance abuse, schizoaffective disorders, schizophrenia, bipolar disorder, organic disorders diagnosed via Mini International Neuropsychiatric Interview (MINI)

Study Details

Locations

Medical University Vienna — Vienna, Austria

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