Clinical trial NCT02860169: Motivation, Brain Function and Mood in Individuals With Cold and/or Flu
Official title: Effects of Cold and/or Flu on Motivation, Mood and Cognitive Performance in Otherwise Healthy Individuals
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cognition
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aim to adapt and test a novel indication of motivation in participants with cold \& flu using the Picture Surfing Task (PST). The purpose of this task, in both healthy participants and those with cold \& flu, will be to provide a measure of: 1) change in general motivation, 2) change in cold and flu-specific motivation, and 3) any change in general tendency to exert force to serve as a control.

Detailed description: The study is designed in three parts. The first, Part A, is an online survey to select salient images (cold \& flu related) to be used in the motivation task under investigation in Parts B and C. Part B is a pilot investigation of a novel measure of motivation, using a grip force cognitive task (PST, previously used in obesity literature) in a small group of participants with cold and flu compared to a group without. The result of this pilot study will inform task content and sample size for Part C. The final part will investigate the effects of cold and flu on motivation (using the PST), cognitive performance (using the Cambridge Cognition Cognitive Assessments \[CANTAB\] testing battery) and subjective mood and motivation in participants suffering from C\&F and healthy participants.

Eligibility criteria: Inclusion Criteria:

* Part A: Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary informed consent confirmed online before completing the online survey.
* Part B and C: Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Aged between 18 and 65 years inclusive.
* Participant is male or female.
* Part A: Healthy adult with no chronic illness and currently free from acute illness.
* Part B and C: Good general and mental health with, in the opinion of the Investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history. Healthy group: Healthy adult with no chronic illness. Currently free from acute illness.

Exclusion Criteria:

* Woman who are known to be pregnant or who are intending to become pregnant over the duration of the study or who are breast-feeding.
* Parts B and C: Current (within 14 days of the start of the study) or regular use of any prescription, OTC and herbal medicine unless it will not interfere with study endpoints as determined by the principal investigator. Vitamin supplements and occasional doses of OTC paracetamol for pain relief/ treatment of cold and flu symptoms are permitted (with the exception of \> 24 hours before study visits).
* Current or in the 30 days prior to dosing use of any drug known to induce or inhibit hepatic drug metabolism (e.g. barbiturates, theophylline, cimetidine, or erythromycin).
* Current or past use (within 2 years) if antidepressants or other psychoactive medication.
* Use of over the counter (OTC) analgesics/cold and flu treatments 24 hours prior to assessment visits in all parts of the study.
* Participant is colour blind.
* Recent history (within the last 5 years) of alcohol or other substance abuse.
* Participant must not be regular smokers (as defined - more than 3 per day or equivalent for e-cigarettes, chewing tobacco or pipes).
* Participant must not consume greater than 21 units of alcohol per week (male) and 14 units per week (female).

Primary outcomes:
measure: Liking Rating on 11 Point Likert Scale (0-10 - 0 = Not at All; 10 = Like Extremely)
timeFrame: At Screening
measure: Change in Reaction Time (RTI) Milliseconds (ms) From the Reaction Time Task in Participants Suffering From Cold and Flu Versus Healthy Participants
timeFrame: Day 1
measure: Change in Emotional Recognition Task (ERT) Score (Number of Total Hits) in Participants Suffering From Cold and Flu Versus Healthy Participants
timeFrame: Day 1
measure: Change in Rapid Visual Information Processing (RVP) A Prime (RVP A') in Participants Suffering From Cold and Flu Versus Healthy Participants
timeFrame: Day 1
measure: Change in Attention Switching Task (AST) Score (Congruency Cost [ms]) in Participants Suffering From Cold and Flu Versus Healthy Participants
timeFrame: Day 1
measure: Change in Mood and Motivation Visual Analogue Scale (VAS) Change (Millimeter[mm]) in Participants Suffering From Cold and Flu Versus Healthy Participants
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Brentford
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: