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

NCT04843462 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-05-24

No results posted yet for this 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

Conditions

Interventions

DEVICE

edupression.com®

Edupression.com® is an evidence-based self-help program that was developed for the treatment of mild to moderate unipolar depression. It is based on two core foundations, psychoeducation with elements of cognitive behavior therapy (CBT) and a mood chart. Both foundations are registered as a medical product. As such, detailed risk management documentation includes probability and severity of adverse events. Moreover, detailed strategies such as warnings were implemented in the software and documented accordingly. It can be used on a PC as well as on mobile devices (browser, app) at any time.

DRUG

Esketamine nasal spray

All patients included in this study are receiving esketamine nasal spray as treatment-as-usual

Sponsors & Collaborators

  • Lukas Pezawas

    lead OTHER

Principal Investigators

  • Markus Dold, MD., Priv.Doz. · Medical University of Vienna

  • Gabriele Fischer, MD, Prof. · Medical University of Vienna

  • Lukas M Pezawas, MD, Prof. · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2023-04-14
Completion
2023-04-14

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04843462 on ClinicalTrials.gov