Add-on Therapy With Edupression.Com® on Therapy Resistant Depressive Patients Treated With Nasal Esketamine Spray (Esketamin+)
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| ClinicalTrials.gov Identifier: NCT04843462 |
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Recruitment Status :
Recruiting
First Posted : April 13, 2021
Last Update Posted : April 28, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder Therapy Resistant Depression | Device: edupression.com® Drug: Esketamine nasal spray | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 70 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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". |
| Masking: | Single (Participant) |
| Masking Description: | Data will be immediately pseudonymized and stored as a master list at the internal server of the MUV (Medical University Vienna). The study staff will only have access to the master list and only the principal investigator and study director will have access to the pseudonymization list. This locked place will be located at the clinic (MUV). All non-personal pseudonymized research relevant data are stored in a master list on a server of the research group at the MUV, to which study staff has access. |
| Primary Purpose: | Treatment |
| 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 |
| Estimated Study Start Date : | April 29, 2021 |
| Estimated Primary Completion Date : | April 11, 2022 |
| Estimated Study Completion Date : | April 11, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: edupression.com® + treatment-as-usual
Patients are receiving treatment with edupression.com® in addition to TAU (treatment-as-usual) with esketamine nasal spray
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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 |
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Active Comparator: treatment-as-usual
Patients are receiving TAU (treatment-as-usual) with esketamine nasal spray
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Drug: Esketamine nasal spray
All patients included in this study are receiving esketamine nasal spray as treatment-as-usual |
- Therapy response (observer-rated) [ Time Frame: 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 [ Time Frame: 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
- Therapy response (self-rated) [ Time Frame: 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843462
| Contact: Lukas M Pezawas, MD, Prof. | 004314040035470 | lukas.pezawas@meduniwien.ac.at | |
| Contact: Gabriele Fischer, MD, Prof. | 004314040035470 | gabriele.fischer@meduniwien.ac.at |
| Austria | |
| Medical University Vienna | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Lukas M Pezawas, Prof. lukas.pezawas@meduniwien.ac.at | |
| Study Chair: | Markus Dold, MD., Priv.Doz. | Medical University of Vienna | |
| Study Chair: | Gabriele Fischer, MD, Prof. | Medical University of Vienna | |
| Principal Investigator: | Lukas M Pezawas, MD, Prof. | Medical University of Vienna |
| Responsible Party: | Lukas Pezawas, Assoc.Prof. Priv.Doz. Dr. Lukas Pezawas, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT04843462 |
| Other Study ID Numbers: |
2467/2020 |
| First Posted: | April 13, 2021 Key Record Dates |
| Last Update Posted: | April 28, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Depression Esketamine Treatment resistant depression Internet-based intervention Telemedicine |
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Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Behavioral Symptoms |
Mood Disorders Mental Disorders Esketamine Antidepressive Agents Psychotropic Drugs |