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 healthy participants.
Detailed description
Randomised, placebo controlled, double blind, cross-over design Primary study outcomes are: Performance in picturial and verbal memory tasks. Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and motivation. Once daily oral administration of placebo mannitol for 7 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 7 days.
DRUGPlacebo
Once daily oral administration of placebo mannitol for 7 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
* Healthy * Male or female * Normotensive * BMI between 20 and 27 kg/m2 * Aged between 18 and 40 years * Native or fluent German-speaking * Caucasian * Female practicing safe contraception
Exclusion criteria
* Acute or chronic psychiatric or somatic disorder * Any contraindication against aspirin or other NSAIDS * History of coagulation disease * History of gastrointestinal disease * Laboratory
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in performance in episodic memory task as assessed by a picturial memory task between placebo and verum at two different timepoints | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. | Picture task as described in (de Quervain, Kolassa et al. 2007). Number of correctly remembered pictures is counted. |
| Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h 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 |
|---|---|---|
| Mood state changes between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. | Mood state as assessed by self-rating instrument MDBF. Total score is calculated by summing the answers of nine items. |
| Changes in depressive symptoms between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. | Depressive symptoms as assessed by self-rating instrument MADRS.Total score is calculated by summing the answers of nine items. |
| Change in performance in working memory task between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. | Working memory as assessed by digit span task. Number of correctly remembered digitsis counted. |
| Change in motivation between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. | Motivation is assessed by a visual analogue scale ranging between 0 and 10. |
| Change in anxiety symptoms between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. | Anxiety symptoms as assessed by self-rating instrument STAI-G from X1 (state). Total score is calculated by summing the answers. |
| Change in performance in a cognitive task between placebo and verum at two different time points. | Timepoint 1:45 minutes after first medication. Timepoint 2: 24 h after last medication. | Cognitive performance as assessed by BOMAT matrix reasoning task. Number of correct solutions is counted. |
Countries
Switzerland
Outcome results
None listed