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

NCT04843462 · Esketamin+ · Lukas Pezawas

Closed to entry
Status
Not accepting participants
Not applicable
Phase
70
Target enrolment
1
Study sites
Outside the US

What it is testing

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Therapy response (observer-rated)

    Measured over At week 4, 8 and 12 after baseline

  • Percentage of received esketamine treatments in relation to scheduled ones

    Measured over Percentage of received esketamine treatments in relation to scheduled ones after 12 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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: * 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)

Where

1 study site

FacilityCityRegionCountry
Medical University ViennaVienna—Austria

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04843462 on ClinicalTrials.gov →

Last updated in the registry 2022-05-24. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance