Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress

NCT ID: NCT02904109

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-13
• Study Completion Date: 2017-02-28

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Verum/Placebo

This group will start with triflusal and after washout will receive placebo.

Group Type: EXPERIMENTAL

Triflusal

Intervention Type: DRUG

Once daily oral administration of 600 mg triflusal Disgren® for 8 days.

Placebo

Intervention Type: DRUG

Once daily oral administration of placebo mannitol for 8 days.

Placebo/Verum

This group will start with placebo and will receive triflusal after washout.

Group Type: EXPERIMENTAL

Triflusal

Intervention Type: DRUG

Once daily oral administration of 600 mg triflusal Disgren® for 8 days.

Placebo

Intervention Type: DRUG

Once daily oral administration of placebo mannitol for 8 days.

Interventions

Triflusal

Once daily oral administration of 600 mg triflusal Disgren® for 8 days.

Intervention Type: DRUG

Placebo

Once daily oral administration of placebo mannitol for 8 days.

Intervention Type: DRUG

Other Intervention Names

Disgren®; mannitol

Eligibility 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
• 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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Dominique de Quervain, MD

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dominique de Quervain, MD

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Basel, Division of Cognitive Neuroscience

Basel, Basel, Switzerland

Countries

Switzerland

Other Identifiers

2016DR2116

Identifier Type: -

Identifier Source: org_study_id