Clinical trial NCT04843462: Add-on Therapy With Edupression.Com® on Therapy Resistant Depressive Patients Treated With Nasal Esketamine Spray
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Therapy Resistant Depression
Keywords: Depression
Esketamine
Treatment resistant depression
Internet-based intervention
Telemedicine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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".
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Therapy response (observer-rated)
timeFrame: At week 4, 8 and 12 after baseline
measure: Percentage of received esketamine treatments in relation to scheduled ones
timeFrame: Percentage of received esketamine treatments in relation to scheduled ones after 12 weeks
Secondary outcomes:
measure: Therapy response (self-rated)
timeFrame: At week 4, 8 and 12 after baseline
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University of Vienna
name: Markus Dold, MD., Priv.Doz.
role: STUDY_CHAIR
affiliation: Medical University of Vienna
name: Gabriele Fischer, MD, Prof.
role: STUDY_CHAIR
affiliation: Medical University of Vienna
name: Lukas M Pezawas, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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. Available from http://www.ncbi.nlm.nih.gov/books/NBK63748/
citation: 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.