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

NCT04843462 | Unknown DMC

• 1 other identifier: 2467/2020
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depressive Disorder; Therapy Resistant Depression

Keywords

Depression; Esketamine; Treatment resistant depression; Internet-based intervention; Telemedicine

Outcome Measures

Primary Outcomes (2)

• Therapy response (observer-rated)

  Change in depressive symptoms according to MADRS-Score (0-60 points, higher values stand for)

  At week 4, 8 and 12 after baseline

• Percentage of received esketamine treatments in relation to scheduled ones

  Change in therapy adherence according to a percentual increase of received esketamine treatments in accordance to scheduled ones

  Percentage of received esketamine treatments in relation to scheduled ones after 12 weeks

Secondary Outcomes (1)

• Therapy response (self-rated)

  At week 4, 8 and 12 after baseline

Study Arms (2)

edupression.com® + treatment-as-usual

EXPERIMENTAL

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

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

treatment-as-usual

ACTIVE COMPARATOR

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

Drug: Esketamine nasal spray

Interventions

edupression.com® DEVICE

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.

edupression.com® + treatment-as-usual

Esketamine nasal spray DRUG

All patients included in this study are receiving esketamine nasal spray as treatment-as-usual

edupression.com® + treatment-as-usual; treatment-as-usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lukas Pezawas: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (2)

• 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/

  PMID: 22132433 RESULT

• 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.

  PMID: 32775969 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Markus Dold, MD., Priv.Doz.

  Medical University of Vienna

  STUDY CHAIR

• Gabriele Fischer, MD, Prof.

  Medical University of Vienna

  STUDY CHAIR

• Lukas M Pezawas, MD, Prof.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas M Pezawas, MD, Prof.

CONTACT

004314040035470; lukas.pezawas@meduniwien.ac.at

Gabriele Fischer, MD, Prof.

CONTACT

004314040035470; gabriele.fischer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc.Prof. Priv.Doz. Dr. Lukas Pezawas

Model Details: 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".

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 13, 2021
• Study Start: April 29, 2021
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)