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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum/Placebo | Experimental | This group will start with triflusal and after washout will receive placebo. |
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| Placebo/Verum | Experimental | This group will start with placebo and will receive triflusal after washout. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triflusal | Drug | Once daily oral administration of 600 mg triflusal Disgren® for 8 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 * | Verbal task as described in ( de Quervain, Henke et al. 2003). Number of correctly remembered words is counted. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in performance in working memory task between placebo and verum at two different time points. | Working memory as assessed by digit span task. Number of correctly remembered digitsis counted. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. |
| Change in performance in episodic memory task between placebo and verum at two different time points. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Basel, Division of Cognitive Neuroscience | Basel | Basel | 4055 | Switzerland |
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| ID | Term |
|---|---|
| C016167 | triflusal |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Placebo | Drug | Once daily oral administration of placebo mannitol for 8 days. |
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Episodic memory is assessed by the visual/spatial and verbal memory test VVM (Building und roadmap) (Quiske 2000). Number of correct answers is counted |
| Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. |
| Change in performance in a memory game between placebo and verum at two different time points. | 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 | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. |
| Change in subjective memory impairment between 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. | 20 min before last medication of each placebo and verum |
| Mood state changes between placebo and verum at two different time points. | Mood state as assessed by self-rating instrument MDBF. Total score is calculated by summing the answers of nine items. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. |
| Changes in depressive symptoms between placebo and verum at two different time points. | Depressive symptoms as assessed by self-rating instrument MADRS. Total score is calculated by summing the answers of nine items. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. |
| Changes in anxiety symptoms between placebo and verum at two different time points. | Anxiety symptoms as assessed by self-rating instrument STAI-G from X1 (state). Total score is calculated by summing the answers. | Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication. |