Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02904109
• Date of registration: 12/09/2016
• Prospective Registration: Yes
• Primary sponsor: Prof. Dominique de Quervain, MD
• Public title: Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress Tricross-Basel
• Scientific title: Randomized Placebo Controlled Phase II Cross Over Study on the Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress
• Date of first enrolment: September 13, 2016
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02904109
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Switzerland

Key inclusion & exclusion criteria

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 exclusion criteria: clinically significant values of blood count (incl.
platelets), coagulation status or blood chemistry outside reference range of
laboratory

- pathological ECG

- known or suspected non-compliance, drug or alcohol abuse

- inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant

- participation in another study with investigational drug within the 30 days preceding
-



Age minimum: 18 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Triflusal

Drug: Placebo

Primary Outcome(s)

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 * [Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.]

Secondary Outcome(s)

Change in performance in working memory task between placebo and verum at two different time points. [Time Frame: 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. [Time Frame: 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. [Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.]

Mood state changes between placebo and verum at two different time points. [Time Frame: 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. [Time Frame: 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. [Time Frame: Timepoint 1:45 minutes after first medication. Timepoint 1:45 minutes after last medication.]

Change in subjective memory impairment between placebo and verum [Time Frame: 20 min before last medication of each placebo and verum]

Secondary ID(s)

2016DR2116

Source(s) of Monetary Support

Please refer to primary and secondary sponsors