Trial document




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  DRKS00000021

Trial Description

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Title

Olanzapine augmentation therapy in treatment-resistent depression: a double-blind placebo-controlled trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The study is using a randomized double blind, placebo-controlled design. 30 patients per treatment group will be included into the study. Psychotic features will be excluded by a ascore of 2 or less in the PANSS subscales P1, P3 and P6. Treatment resistance as defined by history of non-response to 2 antidepressants from different classes at an acceptable dose and period is confirmed retrospectively. Patients will receive a double-blind therapy of either 10 mg/d Olanzapine or placebo. After 14 days, the patients will be classified as responders or non.-responders. A responder is defined by a reduction of the initial HAM-D score of more than 50 %. Study treatment will be stopped in non-responders and continued in a double-blind manner in responders for further 60 days.

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Organizational Data

  •   DRKS00000021
  •   2008/09/05
  •   2006/01/04
  •   yes
  •   Approved
  •   309/03, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   NCT00273624  (Clinical Trials.gov)
  •   UKF000704  (UKFReg)
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Health Condition or Problem studied

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

  •   Olanzapine 10 mg/day
  •   placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

A responder is defined by a reduction of the initial HAM-D score of more than 50 %.

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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

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  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

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  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

- major depression without psychotic features (DSM-IV definition)
- therapy resistance (two courses of antidepressant from different classes > 3 weeks in adequate dose), HAM-D more or equal 17
- age: 18-65

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Exclusion Criteria

- bipolar disorder
- active alcohol or illicit drug use
- female without effective contraception
- severe medical conditions, epilepsy
- psychotic features ( P1, P3 an P6 more or equal 2 at inclusion)

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Addresses

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    • Universitätsklinikum Freiburg
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abt. Psychiatrie und Psychotherapie
    • Mr.  Dr. med.  Claus  Normann 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abt. Psychiatrie und Psychotherapie
    • Mr.  Dr. med.  Claus  Normann 
    • Hauptstr. 5
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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