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

Not Applicable

• Conditions: Therapy Resistant Depression; Major Depressive Disorder
• Interventions: Drug: Esketamine nasal spray; Device: edupression.com®

• Registration Number: NCT04843462
• Lead Sponsor: Lukas Pezawas

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.

Study Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-13
• Study Start: 2021-04-29
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment-as-usual	Esketamine nasal spray	Patients are receiving TAU (treatment-as-usual) with esketamine nasal spray
edupression.com® + treatment-as-usual	edupression.com®	Patients are receiving treatment with edupression.com® in addition to TAU (treatment-as-usual) with esketamine nasal spray
edupression.com® + treatment-as-usual	Esketamine nasal spray	Patients are receiving treatment with edupression.com® in addition to TAU (treatment-as-usual) with esketamine nasal spray

Primary Outcome Measures

Name	Time	Method
Therapy response (observer-rated)	At week 4, 8 and 12 after baseline	Change in depressive symptoms according to MADRS-Score (0-60 points, higher values stand for)
Percentage of received esketamine treatments in relation to scheduled ones	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

Secondary Outcome Measures

Name	Time	Method
Therapy response (self-rated)	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)

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria