Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000008

Trial Description

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Title

Effect of antidepressants on the activity of stress-responsive systems

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Randomized-open, 4-week antidepressant therapy with venlafaxine vs. mirtazapine in patients with unipolar depression as well as 6-month follow-up

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Brief Summary in Scientific Language

Randomized-open, 4-week antidepressant therapy with venlafaxine vs. mirtazapine in patients with unipolar depression as well as 6-month follow-up

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Organizational Data

  •   DRKS00000008
  •   2008/09/05
  •   [---]*
  •   yes
  •   Approved
  •   0255.6, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   Mirtazapin
  •   venlafaxine
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

Hamilton Depression Rating Scale:
<8 = remission
-50% = response

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2003/04/15
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

major depression (DSM-IV)
Hamilton Depression Rating Scale-21 item version: at least 18

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Exclusion Criteria

bipolar depression
Depression due to an organic or substance factor
substance dependency
lifetime diagnosis of schizophrenia
glucocorticoid therapy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • DFG - Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2007/12/31
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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.