Motivation, Brain Function and Mood in Individuals With Cold and/or Flu

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Experimental
  Participants with cold and flu

  Eligible participants with cold and flu were instructed to answer the self administered questionnaire and participate in the assessment that included Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP

  Behavioral: Participants self-administered questionnaire and assessment

• Placebo comparator
  Healthy participants

  Eligible healthy participants were instructed to answer the self administered questionnaire and participate in the assessment that included Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP

  Behavioral: Participants self-administered questionnaire and assessment

Interventions

• BehavioralParticipants self-administered questionnaire and assessment

  Participants self-administered questionnaire and assessment includes Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP.

Primary outcomes

1. Liking Rating on 11 Point Likert Scale (0-10 - 0 = Not at All; 10 = Like Extremely)

   Participants will be asked to rate a selection of images relevant to cold and flu on an 11 point Likert scale of "how much do you like this image?" from 0 = "Not at all" to 10 = "Extremely like" (In Part A of the study).

   Time frame: At Screening

2. Change in Reaction Time (RTI) Milliseconds (ms) From the Reaction Time Task in Participants Suffering From Cold and Flu Versus Healthy Participants

   Change in RTI will be measured by the five-choice reaction time task. The participant will hold down a button at the bottom of the screen until a yellow spot appears in one of the five circles at the top of the screen. Median from five-choice reaction time (the median duration between the onset of the stimulus and the release of the button) will be measured (In Part B of the study).

   Time frame: Day 1

3. Change in Emotional Recognition Task (ERT) Score (Number of Total Hits) in Participants Suffering From Cold and Flu Versus Healthy Participants

   Change in ERT will be measured by displaying Morphed images of real participant's facial features, each showing a specific emotion on the screen for 200ms. The participant will need to decide from 6 options which emotion the face is displaying. Change in ERT (total hits) which is calculated from the number of problems during assessment blocks, on which the participant chose the correct emotion (In Part B of the study).

   Time frame: Day 1

4. Change in Rapid Visual Information Processing (RVP) A Prime (RVP A') in Participants Suffering From Cold and Flu Versus Healthy Participants

   RVP A Prime will be measured with the help of a white box appears in the centre of computer screen inside which digits, from 2 to 9, appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the press pad. RVP A Prime is the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range is 0.00 to 1.00; bad to good). In essence, this metric is a measure of how good the participant is at detecting target sequences (In Part B of the study).

   Time frame: Day 1

5. Change in Attention Switching Task (AST) Score (Congruency Cost [ms]) in Participants Suffering From Cold and Flu Versus Healthy Participants

   Change in AST score is a measure of executive attention. The test displays an arrow which can appear on either side of the screen (right or left) and can point in either direction (to the right or to the left). Each trial displays a cue at the top of the screen that indicates to the participant whether they have to press the right or left button according to the "side on which the arrow appeared" or the "direction in which the arrow was pointing". AST congruency cost (median; ms) will be measured as the difference between the median latency of response (from stimulus appearance to button press) on the trials that were congruent versus the trials that were incongruent. Calculated by subtracting the median congruent latency (ms) from the median incongruent latency. Close to zero: less variation in latencies across congruent and incongruent trials. A positive score: participant is faster on congruent trials and a negative score: participant is faster on incongruent trials (in Part C).

   Time frame: Day 1

6. Change in Mood and Motivation Visual Analogue Scale (VAS) Change (Millimeter[mm]) in Participants Suffering From Cold and Flu Versus Healthy Participants

   VAS of 100mm line will be used to assess subjective ratings of mood and motivation. For mood participants will be asked to rate their current mood under the headings of alertness, pleasure/displeasure and anxiety. Motivation will be assessed by asking participants to rate their current motivation under six different headings e.g. general motivation, motivation to engage with friends and family and motivation to perform leisure activities (In Part B of the study).

   Time frame: Day 1

Baseline characteristics