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

Major Depressive Disorder Clinical Trial

— Esketamin+  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04843462
• Other study ID #: 2467/2020
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: April 14, 2023

Study information

• Verified date: May 2022
• Source: Medical University of Vienna
• Contact: Lukas M Pezawas, MD, Prof.
• Phone: 004314040035470
• Email: lukas.pezawas[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder
• Therapy Resistant Depression

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Lukas Pezawas

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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 cogni — View Citation

National Collaborating Centre for Mental Health (UK). Depression: The Treatment and Management of Depression in Adults (Updated Edition). Leicester (UK): British Psychological Society; 2010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapy response (observer-rated)	Change in depressive symptoms according to MADRS-Score (0-60 points, higher values stand for)	At week 4, 8 and 12 after baseline
Primary	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	Percentage of received esketamine treatments in relation to scheduled ones after 12 weeks
Secondary	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)	At week 4, 8 and 12 after baseline