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 |
| Protocol serial number | KE 595/7 |
| Sponsor | Individual Sponsor (Germany) |
| Funders | Deutsche Forschungsgemeinschaft (DFG), For psychophysiological and autonomous parameters only: Lundbeck |
- Submission date
- 22/08/2005
- Registration date
- 16/09/2005
- Last edited
- 06/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Kellner
Scientific
Scientific
c/o University Hospital Hamburg
Dept of Psychiatry
Martinistrasse 52
Hamburg
20246
Germany
| Phone | +49 40 428032234 |
|---|---|
| kellner@uke.uni-hamburg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | International |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | SSRIs |
| Primary outcome measure(s) |
PANAS under basal conditions and IDCL for panic items and 100 mm VAS for 'anxiety' and 'tension' after CCK-4 challenge |
| Key secondary outcome measure(s) |
Other psychometric, neuropsychological, autonomous, psychophysiological and neuroendocrine parameters |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
c/o University Hospital Hamburg
Hamburg
20246
Germany
20246
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/05/2010 | Yes | No |
