Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00012824

Trial Description

start of 1:1-Block title

Title

Autonomic Modulation in inpatients during a depressive episode

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Recent investigations unveiled diminished autonomic modulation in depressive patients, e.g. less adjustment of the heart rate or blood pressure to situational demands. To quantify autonomic modulation we measure cardiovascular signals (e.g. heart rate, blood pressure) over different situations.
Autonomic testing takes place on the first day of inpatient care and after 3 weeks. Inpatients between 18 and 65 with moderate or severe depressive episode can take part in the investigation.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The current study aims to investigate the influence of inpatient care on autonomic modulation during a depressive episode. The study design is naturalistic, our sample should be similar to the total population of depressive inpatients. Standardised measurement procedure consisting of resting state, metronomic breathing, two Valsalva maneuvers and active orthostasis is performed on every subject on the first day of inpatient care and 3 weeks later. Our goal is to include 30 inpatients in our investigation.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012824
  •   2017/08/10
  •   [---]*
  •   yes
  •   Approved
  •   017/1357, Freiburger Ethik-Kommission International
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   30 inpatients with depressive episode: To quantify autonomic modulation the cardiovascular signals (e.g. heart rate, blood pressure) will be observed in various situations (relaxed or active). The investigation includes Baseline measurement procedure consisting of resting state, metronomic breathing, two Valsalva maneuvers and active orthostasis. Autonomic testing takes place on the first day of inpatient care and after three weeks.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Baroreflex sensitivity, monitored (on the first day of inpatient care and after three weeks) and calculated during both autonomic testings.
Baroreflex sensitivity can be calculated if both blood pressure and heart rate are recorded simultaneously. Sequences of simultaneous drop in blood pressure and raise in heart rate or vice versa are detected. The slope of the regression line of change in heart rate and blood pressure equals the baroreflex sensitivity.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Changes in the severity of depressive symptoms, measured by self Rating (Beck Depression Inventory) and health professional Rating (Hamilton Rating Scale for Depression) on the first day of inpatient care and after three weeks.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/06/09
  •   30
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Diagnosis of F32.1 (moderate depressive episode) or F32.2 (severe depressive Episode without psychotic symptoms, inpatient-care for at least 3 weeks, Age between 18 and 65, ability to give one's consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Diseases of the cardiovascular or autonomic nervous system

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Psychiatrie und Psychotherapie Universitätsklinik der Paracelsus Medizinischen Privatuniversität
    • Prof.-Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Klinik für Psychiatrie und Psychotherapie Universitätsklinik der Paracelsus Medizinischen Privatuniversität
    • Ms.  Dr. med.  Katharina  Hösl 
    • Prof.-Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für Psychiatrie und PsychotherapieUniversitätsklinik der Paracelsus Medizinischen Privatuniversität
    • Mr.  M.Sc. Psychologie  Lennard  Geiß 
    • Prof.-Ernst-Nathan-Straße 1
    • 90429  Nürnberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Psychiatrie und Psychotherapie Universitätsklinik der Paracelsus Medizinischen Privatuniversität
    • Mr.  M.Sc. Psychologie  Lennard  Geiß 
    • Prof.-Ernst-Nathan-Straße 1
    • 90429  Nürnberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Psychiatrie und Psychotherapie/Universitätsklinik der Paracelsus Medizinischen Privatuniversität
    • Prof.-Ernst-Nathan-Str. 1
    • 90419  Nürnberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2018/02/19
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.