Status:
UNKNOWN
Add-on Therapy With Edupression.Com® on Therapy Resistant Depressive Patients Treated With Nasal Esketamine Spray
Lead Sponsor:
Lukas Pezawas
Conditions:
Major Depressive Disorder
Therapy Resistant Depression
Eligibility:
All Genders
18+ years
Phase:
NA
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 n...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 14 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04843462
Start Date
April 29 2021
End Date
April 14 2023
Last Update
May 24 2022
Active Locations (1)
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1
Medical University Vienna
Vienna, Austria, 1090