Effect of antidepressants on the activity of stress-responsive systems
Organizational Data
- DRKS-ID:
- DRKS00000008
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2008-09-05
- Last update in DRKS:
- 2017-04-02
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
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
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
Health condition or problem studied
- ICD10:
- F32 - Depressive episode
- ICD10:
- F33 - Recurrent depressive disorder
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Mirtazapin
- Arm 2:
- venlafaxine
Endpoints
- Primary outcome:
- Hamilton Depression Rating Scale: <8 = remission -50% = response
- Secondary outcome:
- No Entry
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- III
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
- No Entry
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2003-04-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2007-12-31
- Target Sample Size:
- 120
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 75 Years
- Additional Inclusion Criteria:
- major depression (DSM-IV) Hamilton Depression Rating Scale-21 item version: at least 18
Exclusion Criteria
bipolar depression Depression due to an organic or substance factor substance dependency lifetime diagnosis of schizophrenia glucocorticoid therapy
Addresses
Primary Sponsor
- Address:
- Zentralinstitut für Seelische GesundheitProf. Dr. med. Michael DeuschleJ568159 MannheimGermany
- Telephone:
- +49 621 1703 2331
- Fax:
- +49 621 1703 2325
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Zentralinstitut für Seelische GesundheitProf. Dr. med. Michael DeuschleJ568159 MannheimGermany
- Telephone:
- +49 621 1703 2331
- Fax:
- +49 621 1703 2325
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Zentralinstitut für Seelische GesundheitProf. Dr. med. Michael DeuschleJ568159 MannheimGermany
- Telephone:
- +49 621 1703 2331
- Fax:
- +49 621 1703 2325
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Zentralinstitut für Seelische GesundheitProf. Dr. med. Michael DeuschleJ568159 MannheimGermany
- Telephone:
- +49 621 1703 2331
- Fax:
- +49 621 1703 2325
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
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.)
- Address:
- DFG - Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- +49 228 885 1
- Fax:
- +49 228 885 2777
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Med. Ethik-Kommission II, Fakultät für Medizin Mannheim, Ruprecht-Karls-Universität Heidelberg [Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg]Prof. Dr. med. Jens-Peter StriebelMaybachstrasse 14-1668169 MannheimGermany
- Telephone:
- +49 621 3363 440
- Fax:
- -49 621 3363 442
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ma.uni-heidelberg.de/inst/ethikkommission/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2003-04-09
- Ethics committee number:
- 0255.6
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2003-04-15
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry