Trial document

PLEASE NOTE:
This trial has been registered retrospectively.

drksid header

DRKS-ID: 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

DRKS-ID: DRKS00000008
Date of Registration in DRKS: 2008/09/05
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 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

ICD10: F32 - Depressive episode
ICD10: F33 - Recurrent depressive disorder

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Interventions/Observational Groups

Arm 1: Mirtazapin
Arm 2: venlafaxine

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Active control
Purpose: Treatment
Assignment: Parallel
Phase: III
Off-label Drug use: [---]*

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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

DE: Germany

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Locations of Recruitment

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2003/04/15
Target Sample Size: 120
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Zentralinstitut für Seelische Gesundheit
- Mr. Prof. Dr. med. Michael Deuschle
- J5
- 68159 Mannheim
- Germany
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- Telephone: +49 621 1703 2331
- Fax: +49 621 1703 2325
- E-mail: michael.deuschle at zi-mannheim.de
- URL: [---]*
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Contact for Scientific Queries
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- Zentralinstitut für Seelische Gesundheit
- Mr. Prof. Dr. med. Michael Deuschle
- J5
- 68159 Mannheim
- Germany
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- Telephone: +49 621 1703 2331
- Fax: +49 621 1703 2325
- E-mail: michael.deuschle at zi-mannheim.de
- URL: [---]*
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Contact for Public Queries
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- Zentralinstitut für Seelische Gesundheit
- Mr. Prof. Dr. med. Michael Deuschle
- J5
- 68159 Mannheim
- Germany
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- Telephone: +49 621 1703 2331
- Fax: +49 621 1703 2325
- E-mail: michael.deuschle at zi-mannheim.de
- URL: [---]*
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- DFG - Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
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- Telephone: +49 228 885 1
- Fax: +49 228 885 2777
- E-mail: postmaster at dfg.de
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2007/12/31

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Trial Publications, Results and other Documents

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