Influence of the polymorphism of the serotonin transporter promoter gene on effects of selective serotonin re-uptake inhibitors (SSRIs) in experimental panic provocation

ISRCTN	ISRCTN04559282
DOI	https://doi.org/10.1186/ISRCTN04559282
Secondary identifying numbers	KE 595/7

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Michael Kellner
Scientific

c/o University Hospital Hamburg
Dept of Psychiatry
Martinistrasse 52
Hamburg
20246
Germany

Phone	+49 40 428032234
Email	kellner@uke.uni-hamburg.de

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	International
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	KE 595/7
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	SSRIs
Primary outcome measure	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 study start date	01/09/2005
Completion date	01/09/2006

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	40 Years
Sex	Not Specified
Target number of participants	30
Key inclusion criteria	Healthy volunteers (age 18-40 years)
Key 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
Date of first enrolment	01/09/2005
Date of final enrolment	01/09/2006

c/o University Hospital Hamburg

Hamburg
20246
Germany

Individual Sponsor (Germany)
University/education

Michael Kellner
c/o University Hospital Hamburg
Dept. of Psychiatry
Martinistrasse 52
Hamburg
20246
Germany

Phone	+49 (0)40 428032234
Email	kellner@uke.uni-hamburg.de

Research council

Deutsche Forschungsgemeinschaft (DFG)
Government organisation / National government

Alternative name(s): German Research Association, German Research Foundation, DFG
Location: Germany

For psychophysiological and autonomous parameters only: Lundbeck

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/05/2010		Yes	No