Condition category
Mental and Behavioural Disorders
Date applied
22/08/2005
Date assigned
16/09/2005
Last edited
06/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes