Trial document





This trial has been registered retrospectively.
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  DRKS00011628

Trial Description

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Title

deprexis®24-NOW
deprexis®24-new online cognitive behavioral therapy with or without pharmacotherapy

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Trial Acronym

deprexis®24-NOW

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aim of this clinical study of a medical device according to §23b MPG is to examine the application and effectiveness of the online-based psychotherapy program deprexis®24 for the therapeutic support of adult patients with depressive mood or depression, with or without comedication. Data are collected under routine conditions over an observation period of 3 months.

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Brief Summary in Scientific Language

Aim of this clinical study of a medical device according to §23b MPG is to examine the application and effectiveness of the online-based psychotherapy program deprexis®24 for the therapeutic support of adult patients with depressive mood or depression, with or without comedication. Data are collected under routine conditions over an observation period of 3 months.
The following questions are to be analyzed:
1) Findings on the use of deprexis®24 in outpatient patients of daily practice
a) Change of depressive symptoms during and after application
b) Influence of the application on the social function of the patient
2) Findings on the treatment effect of deprexis®24 with / without comedication
3) Findings about patient satisfaction with the application of deprexis®24
4) Collection of compliance with the online psychotherapy program
5) Obtaining insights into specific safety-related incidents under deprexis®24 and adverse events (UE) under a possible comedication.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011628
  •   2017/01/26
  •   [---]*
  •   no
  •   Approved
  •   016/1259, Freiburger Ethik-Kommission International
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F32 -  Depressive episode
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Interventions/Observational Groups

  •   Data of ambulatory patients with a depressive mood or depression who use deprexis®24 as an online psychotherapy program according to the current patient information should be documented over an observational period of 3 months under routine care.
    The therapy program can be used by patients with or without antidepressive comedication.
    Patients with or without concomitant diseases should be enrolled into this study. Requirement for the inclusion of patients into this study is, that the treating physician has made the decision for the accompanying use of deprexis24 with the patient.
    There are four assessments of study data (baseline (U1, start of therapy), 2 follow-up visits (U2, U3, approx. 3 and 6 weeks after U1), final examination (U4, approx. 12 weeks after U1). At the individual timepionts of data collection the patient receives various questionnaires (PHQ-9, SDS, CSQ-4, questionnaires for compliance and internet usage).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Aim of this clinical study of a medical device according to §23b MPG is to examine the application and effectiveness of the online-based psychotherapy program deprexis®24 for the therapeutic support of adult patients with depressive mood or depression, with or without comedication. Data are collected under routine conditions over an observation period of 3 months.
The following questions are to be analyzed:
1) Findings on the use of deprexis®24 in outpatient patients of daily practice
a) Change of depressive symptoms during and after application (short version Montgomery Asberg Depression Scale (svMADRS), Clinical Global Impression-Severity/Improvement (CGI-S / CGI-I), Patient Health Questionnaire (PHQ-9); at all 4 visits (U1-U4))
b) Influence of the application on the social function of the patient (Sheehan Disability Scale (SDS); at all 4 visits (U1-U4))
2) Findings on the treatment effect of deprexis®24 with / without comedication (standardized documentation; at all 4 visits (U1-U4))
3) Findings about patient satisfaction with the application of deprexis®24 (Client Satisfaction Questionnaire (CSQ-4); U4)
4) Collection of compliance with the online psychotherapy program (standardized Questionnaire; U2-U4)
5) Obtaining insights into specific safety-related incidents under deprexis®24 and adverse events (UE) under a possible comedication (standardized Questionnaire; U2-U4).

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/11/02
  •   1800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Ambulatory patients with a depressive mood or depression who use deprexis®24 as an online psychotherapy program according to the current patient information.

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Exclusion Criteria

Patients under 18 years

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Addresses

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    • Servier Deutschland GmbH
    • Elsenheimerstr. 53
    • 80687  München
    • Germany
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    •   089/57095-01
    •   [---]*
    •   [---]*
    •   [---]*
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    • Servier Deutschland GmbH
    • Ms.  Dr. med.  Bettina  Barthel 
    • Elsenheimerstr. 53
    • 80687  München
    • Germany
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    • Servier Deutschland GmbH
    • Ms.  Dr. med.  Bettina  Barthel 
    • Elsenheimerstr. 53
    • 80687  München
    • Germany
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Sources of Monetary or Material Support

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    • Servier Deutschland GmbH
    • Elsenheimerstr. 53
    • 80687  München
    • Germany
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    •   089/57095-01
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2018/04/24
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Trial Publications, Results and other Documents

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