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

May 23, 2022 updated by: Lukas Pezawas

A Randomized, Controlled Pragmatic Trial Assessing the Value of an add-on Therapy With Edupression.Com® in Therapy Resistant Depressive Patients Treated With Esketamine Nasal Spray

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: edupression.com® + treatment-as-usual
Patients are receiving treatment with edupression.com® in addition to TAU (treatment-as-usual) with esketamine nasal spray
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
ACTIVE_COMPARATOR: treatment-as-usual
Patients are receiving TAU (treatment-as-usual) with esketamine nasal spray
Drug: Esketamine nasal spray
All patients included in this study are receiving esketamine nasal spray as treatment-as-usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapy response (observer-rated)
Time Frame: At week 4, 8 and 12 after baseline
Change in depressive symptoms according to MADRS-Score (0-60 points, higher values stand for)
At week 4, 8 and 12 after baseline
Percentage of received esketamine treatments in relation to scheduled ones
Time Frame: Percentage of received esketamine treatments in relation to scheduled ones after 12 weeks
Change in therapy adherence according to a percentual increase of received esketamine treatments in accordance to scheduled ones
Percentage of received esketamine treatments in relation to scheduled ones after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapy response (self-rated)
Time Frame: At week 4, 8 and 12 after baseline
Change in depressive symptoms according to the self rating scale PHQ-9 (Patient Health Questionnaire-9) (1-27 points, higher values stand for increased severity)
At week 4, 8 and 12 after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lukas Pezawas

Investigators

  • Study Chair: Markus Dold, MD., Priv.Doz., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 29, 2021

Primary Completion (ANTICIPATED)

April 14, 2023

Study Completion (ANTICIPATED)

April 14, 2023

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 12, 2021

First Posted (ACTUAL)

April 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2467/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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