Trial document
This trial has been registered retrospectively.
drksid header
DRKS00000008
Trial Description
start of 1:1-Block title
Title
Effect of antidepressants on the activity of stress-responsive systems
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
Randomized-open, 4-week antidepressant therapy with venlafaxine vs. mirtazapine in patients with unipolar depression as well as 6-month follow-up
end of 1:1-Block public summary
start of 1:1-Block scientific synopsis
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
end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data
Organizational Data
- DRKS00000008
- 2008/09/05
- [---]*
- yes
- Approved
- 0255.6, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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 - Depressive episode
- F33 - Recurrent depressive disorder
end of 1:N-Block indications
start of 1:N-Block interventions
Interventions/Observational Groups
- Mirtazapin
- venlafaxine
end of 1:N-Block interventions
start of 1:1-Block design
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Open (masking not used)
- [---]*
- Active control
- Treatment
- Parallel
- III
- [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint
Primary Outcome
Hamilton Depression Rating Scale:
<8 = remission
-50% = response
end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint
Secondary Outcome
[---]*
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
- [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment
Recruitment
- Actual
- 2003/04/15
- 120
- Monocenter trial
- National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria
Inclusion Criteria
- Both, male and female
- 18 Years
- 75 Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add
Additional Inclusion Criteria
major depression (DSM-IV)
Hamilton Depression Rating Scale-21 item version: at least 18
end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria
Exclusion Criteria
bipolar depression
Depression due to an organic or substance factor
substance dependency
lifetime diagnosis of schizophrenia
glucocorticoid therapy
end of 1:1-Block exclusion criteria
start of 1:n-Block addresses
Addresses
-
start of 1:1-Block address primary-sponsor
- Zentralinstitut für Seelische Gesundheit
- Mr. Prof. Dr. med. Michael Deuschle
- J5
- 68159 Mannheim
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49 621 1703 2331
- +49 621 1703 2325
- michael.deuschle at zi-mannheim.de
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Zentralinstitut für Seelische Gesundheit
- Mr. Prof. Dr. med. Michael Deuschle
- J5
- 68159 Mannheim
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 621 1703 2331
- +49 621 1703 2325
- michael.deuschle at zi-mannheim.de
- [---]*
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
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 621 1703 2331
- +49 621 1703 2325
- michael.deuschle at zi-mannheim.de
- [---]*
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
- DFG - Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +49 228 885 1
- +49 228 885 2777
- postmaster at dfg.de
- [---]*
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
- 2007/12/31
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.