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.

Led by Lukas Pezawas from the Medical University of Vienna, the study aims to determine whether digital therapy with edupression.com® improves clinical outcomes in patients with therapy-resistant depression (TRD) who are already receiving esketamine nasal spray.

Edupression.com® is a licensed computer-based self-help program based on cognitive behavioural therapy, psychoeducation, and mood tracking. Patients assigned to the intervention arm receive full access to edupression.com® in addition to their standard treatment with esketamine nasal spray.

The study targets adults aged 18 or older with an initial MADRS-Score of 22 or above and a diagnosis of therapy-resistant depression according to the European Medicines Agency (EMA). Participants are randomized into two parallel study arms: one receiving edupression.com® alongside esketamine nasal spray (intervention group) and the other receiving only esketamine nasal spray (control group).

Primary outcome measures include observer-rated therapy response based on changes in MADRS-Score and therapy adherence measured by the percentage of received esketamine treatments in relation to scheduled ones. Secondary outcome measures include self-rated therapy response using the PHQ-9 scale.

The study began on April 29, 2021, with an estimated completion date of April 14, 2023. Recruitment is ongoing in Vienna, Austria, and the study is not planning to share individual participant data.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country Austria
Visit trial
Status Recruiting
Results Published No
Start date 29 April 2021
End date 14 April 2023
Phase Not Applicable
Design Blinded
Type Interventional
Generation Second
Participants 70
Sex All
Age 18- 99
Therapy Yes

Trial Details

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

NCT Number NCT04843462

Sponsors & Collaborators

Medical University of Vienna
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Data attribution

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