Healthy
Conditions
Brief summary
The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in participants under chronic stress.
Detailed description
Randomised, placebo controlled, double blind, cross-over design Primary study outcome is: Performance in a verbal memory task. Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and subjective memory impairment. Once daily oral administration of 600 mg triflusal and placebo mannitol for 8 days in a cross-over trial with a washout period of at least 14 days between the two periods. Each participant will take triflusal as well as placebo
Interventions
DRUGTriflusal
Once daily oral administration of 600 mg triflusal Disgren® for 8 days.
DRUGPlacebo
Once daily oral administration of placebo mannitol for 8 days.
Sponsors
Prof. Dominique de Quervain, MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* male or female * normotensive (BP between 90/60mmHg and 140/90mmHg) * BMI between 19 and 29 kg/m2 * aged between 18 and 40 years * experiencing chronic stress for at least 1 month (TICS sum score in subscale overextension at work \>= 55) * native or fluent German-speaking * able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol * willing to donate saliva sample for DNA-analysis * female: willing to perform a pregnancy test at the beginning of both medication phase and at the follow-up visit.
Exclusion criteria
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to salicylates and other NSAIDs * acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency) except symptoms of chronic stress * cognitive impairment as detected by DemTect * concomitant acute or chronic disease state (e.g. renal failure, hepatic dysfunction, cardiovascular disease, acute infections etc.) * women who are pregnant or breast feeding * intention to become pregnant during the course of the study * lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases * active peptic ulcer or antecedents or complicated peptic ulcer or history of peptic ulcer. Any other active pathological bleeding * history of coagulation abnormality * thyroid problems * laboratory
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points. Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly * | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. | Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly remembered words is counted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in performance in episodic memory task between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. | Episodic memory is assessed by the visual/spatial and verbal memory test VVM (Building und roadmap) (Quiske 2000). Number of correct answers is counted |
| Change in performance in a memory game between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. | A memory game consisting of 12 pictures will be used to assess episodic memory.Total score is calculated by summing the correctly located pictures after 3 rounds of the game |
| Change in subjective memory impairment between placebo and verum | 20 min before last medication of each placebo and verum | a two part questionnaire (MIQ) consisting of a 10-item Rasch modeled Memory self-efficacy scale (Zelinski and Gilewski 2004) extended by 6 items as second part.Total score is calculated by summing the answers of each part. |
| Change in performance in working memory task between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. | Working memory as assessed by digit span task. Number of correctly remembered digitsis counted. |
| Changes in depressive symptoms between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. | Depressive symptoms as assessed by self-rating instrument MADRS. Total score is calculated by summing the answers of nine items. |
| Changes in anxiety symptoms between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. | Anxiety symptoms as assessed by self-rating instrument STAI-G from X1 (state). Total score is calculated by summing the answers. |
| Mood state changes between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. | Mood state as assessed by self-rating instrument MDBF. Total score is calculated by summing the answers of nine items. |
Countries
Switzerland
Outcome results
None listed