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Major Depressive DisorderEsketamin+NCT04843462

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

A study testing edupression.com® and Esketamine nasal spray in people with Major Depressive Disorder and Therapy Resistant Depression, run by Lukas Pezawas at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
edupression.com® and Esketamine nasal spray
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteAustria
Study dates
29 Apr 2021to 14 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Lukas M Pezawas, MD, Prof. contact

004314040035470

lukas.pezawas@meduniwien.ac.at

Gabriele Fischer, MD, Prof. contact

004314040035470

gabriele.fischer@meduniwien.ac.at

Austria1 site, 1 recruiting

  • Medical University Vienna

    Vienna, 1090

    Lukas M Pezawas, Prof., lukas.pezawas@meduniwien.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: 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

Read the 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.

Being tested
edupression.com®, Esketamine nasal spray
Keywords
Depression, Esketamine, Treatment resistant depression, Internet-based intervention, Telemedicine
Medical subject headings
Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • edupression.com®Device

    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.

  • Esketamine nasal sprayDrug

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

Study groups in NCT04843462
Study groupRoleWhat they receive
edupression.com® + treatment-as-usualExperimentalPatients are receiving treatment with edupression.com® in addition to TAU (treatment-as-usual) with esketamine nasal spray
Receives: Device: edupression.com®; Drug: Esketamine nasal spray
treatment-as-usualActive comparatorPatients are receiving TAU (treatment-as-usual) with esketamine nasal spray
Receives: Drug: Esketamine nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapy response (observer-rated)

    Change in depressive symptoms according to MADRS-Score (0-60 points, higher values stand for)

    Measured: At week 4, 8 and 12 after baseline

  2. Percentage of received esketamine treatments in relation to scheduled ones

    Change in therapy adherence according to a percentual increase of received esketamine treatments in accordance to scheduled ones

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

Secondary outcomes (1)

  1. Therapy response (self-rated)

    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)

    Measured: At week 4, 8 and 12 after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2021
  2. Study start29 Apr 2021
  3. Primary completion14 Apr 2023 (estimated)
  4. Study completion14 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The interventional study consists of two parallel study arms. The interventional group receives "treatment-as-usual" with nasal esketamine spray and access to edupression.com®. The control group only receives "treatment-as-usual".
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04843462
Sponsor's protocol ID
2467/2020
Acronym
Esketamin+
Status last verified
May 2022
First submitted
7 Apr 2021
Last updated
24 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • National Collaborating Centre for Mental Health (UK). Depression: The Treatment and Management of Depression in Adults (Updated Edition). Leicester (UK): British Psychological Society; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK63748/

    PubMed 22132433

  • Luo C, Sanger N, Singhal N, Pattrick K, Shams I, Shahid H, Hoang P, Schmidt J, Lee J, Haber S, Puckering M, Buchanan N, Lee P, Ng K, Sun S, Kheyson S, Chung DC, Sanger S, Thabane L, Samaan Z. A comparison of electronically-delivered and face to face cognitive behavioural therapies in depressive disorders: A systematic review and meta-analysis. EClinicalMedicine. 2020 Jun 27;24:100442. doi: 10.1016/j.eclinm.2020.100442. eCollection 2020 Jul.

    PubMed 32775969

  • Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20.

    PubMed 39428602

Questions about this trial

What is this clinical trial studying?

A study testing edupression.com® and Esketamine nasal spray in people with Major Depressive Disorder and Therapy Resistant Depression, run by Lukas Pezawas at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lukas M Pezawas, MD, Prof. (004314040035470, lukas.pezawas@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapy response (observer-rated) (time frame: At week 4, 8 and 12 after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04843462, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.

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Esketamin+ Clinical Trial NCT04843462 | AzTrials