Contact information
Type
Scientific
Primary contact
Dr Michael Kellner
ORCID ID
Contact details
c/o University Hospital Hamburg
Dept of Psychiatry
Martinistrasse 52
Hamburg
20246
Germany
+49 40 428032234
kellner@uke.uni-hamburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KE 595/7
Study information
Scientific title
Acronym
KE 595/7
Study hypothesis
SSRIs influence psychometric, neuropsychological, autonomous, psychophysiological and neuroendocrine parameters at basal conditions and during CCK-4 stimulation in healthy volunteers.
There are differences according to the genotype for the promoter for the serotonin transporter.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
International
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Mental and behavioural disorders
Intervention
Treatment with SSRI versus placebo for eight weeks (double-blind, randomized, within-subjects cross-over), CCK-4 challenge on respective days 42
Intervention type
Drug
Phase
Not Specified
Drug names
SSRIs
Primary outcome measures
PANAS under basal conditions and IDCL for panic items and 100 mm VAS for 'anxiety' and 'tension' after CCK-4 challenge
Secondary outcome measures
Other psychometric, neuropsychological, autonomous, psychophysiological and neuroendocrine parameters
Overall trial start date
01/09/2005
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy volunteers (age 18-40 years)
Participant type
Healthy volunteer
Age group
Adult
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
1. Current and life-time psychiatric disorders
2. Medical or neurological illnesses
3. Shift work
4. Transcontinental flights during the past four weeks
Recruitment start date
01/09/2005
Recruitment end date
01/09/2006
Locations
Countries of recruitment
Germany
Trial participating centre
c/o University Hospital Hamburg
Hamburg
20246
Germany
Sponsor information
Organisation
Individual Sponsor (Germany)
Sponsor details
Michael Kellner
c/o University Hospital Hamburg
Dept. of Psychiatry
Martinistrasse 52
Hamburg
20246
Germany
+49 (0)40 428032234
kellner@uke.uni-hamburg.de
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Deutsche Forschungsgemeinschaft (DFG)
Alternative name(s)
German Research Foundation, DFG
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Germany
Funder name
For psychophysiological and autonomous parameters only: Lundbeck
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20381161
Publication citations
-
Results
Hinkelmann K, Dragoi L, Gompf J, Muhtz C, Demiralay C, Yassouridis A, Wiedemann K, Kellner M, Decreased recognition of negative affect after selective serotonin reuptake inhibition is dependent on genotype., Psychiatry Res, 2010, 177, 3, 354-357, doi: 10.1016/j.psychres.2010.03.008.