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

Last updated: May 23, 2022
Sponsor: Lukas Pezawas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Depression (Adult And Geriatric)

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT04843462
2467/2020
  • Ages > 18
  • All Genders

Study Summary

Pragmatic clinical trial of an add-on therapy regarding the use of edupression.com® - a licensed computer based self-help program - on patients with therapy-resistant depression receiving esketamine nasal spray

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 or older
  • Initial MADRS-Score of 22 or above
  • Diagnosis of a therapy-resistant depression following the definition of the EuropeanMedicines Agency (EMA) - absence of remission after two or more guideline-orientedtherapies
  • 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 atleast two devices (such as tablets, computers, smartphones etc)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 70
Study Start date:
April 29, 2021
Estimated Completion Date:
April 14, 2023

Study Description

edupression.com® - is a medical product and computer based self-help program based on cognitive behavioral therapy, psychoeducation and mood tracking. Patients included in the interventional arm of this study are receiving full access to edupression.com®.

Due to limited resources regarding face-to-face therapy and a high prevalence of Major Depressive Disorder - of which 37% can be identified as therapy-resistant depression (TRD) according to the definition of the European Medical Agency (EMA) - low-intensity psychosocial interventions such as edupression.com® are recommended as first-line digital therapeutic agent by international guidelines such as National Institute for Health and Care Excellence (NICE) guidelines. Studies have shown that digital interventions - such as edupression.com - show comparable clinical efficiency to face-to-face therapy and therefore could be able to fill the gap in limited ressources. In this study patients with therapy-resistant depression are receiving therapy with edupression.com® in addition to their treatment-as-usual with esketamine nasal spray. Comparable studies have shown that patients receiving psychotherapy in addition to their medical therapy benefit in regards to their clinical outcome. Considering these findings, this study is aimed to investigate potential clinical benefits in patients receiving digital therapy with edupression®.com as an add-on therapy to their treatment-as-usual therapy with esketamine nasal spray.

Connect with a study center

  • Medical University Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.