Trial document





This trial has been registered retrospectively.
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  DRKS00008935

Trial Description

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Title

Follow-Up Study to the parent study "Comparison of CBASP versus Escitalopram for chronic depression"

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Trial Acronym

CBASP1_FUP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Sixty patients are asked to state their current status regarding depression symptoms and general health with a minimum of 2 years after the intervention study.

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Brief Summary in Scientific Language

The current study is a follow-up investigation of the above mentioned clinical intervention study "Comparison of CBASP versus Escitalopram for chronic depression" with outpatient chronic depressives. A specific form of psychotherapy (CBASP) was compared to medication only for a period of 8 weeks of acute and 20 weeks of extended treatment. In case of non-improvement (<20%) after 8 weeks of acute treatment, patients were offered to augment their initial treatment with the respective other treatment for the remaining 20 weeks.

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Organizational Data

  •   DRKS00008935
  •   2015/08/06
  •   [---]*
  •   yes
  •   Approved
  •   135/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   chronic depression, double depression
  •   F34.1 -  Dysthymia
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Interventions/Observational Groups

  •   patients receiving CBASP in the mother study now fill out questionnaires concerning current depr. symptomatology and general health
  •   patients receiving Escitalopram and clinical management in the mother study now fill out questionnaires concerning current depr. symptomatology and general health
  •   patients receiving combination treatment and in the mother study now fill out questionnaires concerning current depr. symptomatology and general health
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

depressive symptomatology after minimum of 2 years after treatment measured via IDS

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Secondary Outcome

General Health as measured by the WHOWoL-BREF a minimum of 2 years after the mother-study

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/06/19
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

This is a follow-up investigation. Thus only participants of the mother-study were included.

The inclusion criteria were as follows: eligible subjects were between 18 and 65 years old and met the DSM-IV criteria for a current
episode of chronic major depressive disorder (with the modification of at least 1 year of depressive symptomatology) or recurrent
major depressive episodes ( ≥ 3 episodes with the preceding episode no more than 2.5 years before the onset of the current episode). A score of ≥ 18 on the Montgomery-Asberg Depression Scale (MADRS, [24] ) was required. The patients had to be medication free for a minimum of 2 weeks before baseline. Furthermore, the subjects needed to be fluent in German and able to provide written informed consent.

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Exclusion Criteria

The exclusion criteria were as follows: patients were not eligible for the study if they had an acute risk for suicide (as opposed to suicidal thoughts or chronic suicidality) assessed according to clinical practice guidelines. Further exclusion criteria were: a history of psychotic symptoms, bipolar disorder, or dementia; severe substance-
related abuse or dependence disorder; schizotypal, antisocial, or borderline personality disorder; serious medical conditions; severe cognitive impairment, and absence of a response to a previous adequate trial of CBASP or ESC.

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Addresses

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    • Universitätsklinikum FreiburgKlinik für Psychiatrie und Psychotherapie
    • Hauptstraße 5
    • 79104   Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Psychiatrie und Psychotherapie
    • Ms.  Prof. Dr.  Elisabeth  Schramm 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Uniklinikum FreiburgKlinik für Psychiatrie und Psychotherapie
    • Mr.  Paul  Bausch 
    • Hauptstraße 6
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinikum FreiburgKlinik für Psychiatrie und Psychotherapie
    • Hauptstraße 5
    • 79104  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/17
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.