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

Lukas Pezawas

Status: Unknown

Conditions: Therapy Resistant Depression; Major Depressive Disorder

Treatments: Device: edupression.com®; Drug: Esketamine nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04843462

2467/2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

edupression.com® + treatment-as-usual

Experimental group

Description:

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

Treatment:

Drug: Esketamine nasal spray

Device: edupression.com®

treatment-as-usual

Active Comparator group

Description:

Patients are receiving TAU (treatment-as-usual) with esketamine nasal spray

Treatment:

Drug: Esketamine nasal spray