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Completed

NCT Number: NCT02321852

Influence of Triflusal on Cognitive Functions in Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Basel, Division of Cognitive Neuroscience

Basel, 4055, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria: values of blood count, blood chemistry and coagulation status outside normal range
  • Pathological ECG
  • Pregnancy, breast-feeding

Treatment and study plan

Triflusal

Drug

Once daily oral administration of 600 mg triflusal Disgren® for 7 days.

Other names: Disgren®

Placebo

Drug

Once daily oral administration of placebo mannitol for 7 days

Other names: Mannitol

Primary outcomes

  1. Change in performance in episodic memory task as assessed by a picturial memory task between placebo and verum at two different timepoints

    Time frame: 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.

  2. Change in performance in episodic memory task as assessed by a verbal memory task between placebo and verum at two different time points.

    Time frame: 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 outcomes

  1. 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 2: 24 h after last medication.

    Working memory as assessed by digit span task. Number of correctly remembered digitsis counted.

  2. Change in performance in a cognitive task between placebo and verum at two different time points.

    Time frame: 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.

  3. Mood state changes between placebo and verum at two different time points.

    Time frame: 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.

  4. Changes in depressive symptoms between placebo and verum at two different time points.

    Time frame: 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.

  5. Change in anxiety symptoms between placebo and verum at two different time points.

    Time frame: 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.

  6. Change in motivation between placebo and verum at two different time points.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Prof. Dominique de Quervain, MD

Other

Registry information

Official study title

Randomized Placebo Controlled Phase II Cross Over Study on the Influence of Triflusal on Cognitive Functions in Healthy Participants

Acronym: Tribunal-Basel

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 22, 2014
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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