Trial Outcomes & Findings for Motivation, Brain Function and Mood in Individuals With Cold and/or Flu (NCT NCT02860169)
NCT ID: NCT02860169
Last Updated: 2019-04-11
Results Overview
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).
TERMINATED
NA
114 participants
At Screening
2019-04-11
Participant Flow
Participants were recruited from one center at United Kingdom (UK).
This study was divided in 3 parts (A, B and C). Part A was an online survey, Parts B and C. Participants recruited separately for each part of the study based on the inclusion and exclusion criteria of respective part of the study. (46 \[part A\] + 20 \[part B\] + 48 \[part C\] = 114 enrolled in the study)
Participant milestones
| Measure |
Overall Participants
The study consisted of three parts A (includes only healthy participants), B and C (both B and C included healthy and cold and flu participants). Recruitment is done separately for each part of the study, based on the inclusion and exclusion criteria set for the respective part of the study.
|
|---|---|
|
Part A
STARTED
|
46
|
|
Part A
Healthy Participants
|
46
|
|
Part A
Participants With Cold and Flu
|
0
|
|
Part A
COMPLETED
|
35
|
|
Part A
NOT COMPLETED
|
11
|
|
Part B
STARTED
|
20
|
|
Part B
Healthy Participants
|
10
|
|
Part B
Participants With Cold and Flu
|
10
|
|
Part B
COMPLETED
|
9
|
|
Part B
NOT COMPLETED
|
11
|
|
Part C
STARTED
|
48
|
|
Part C
Healthy Participants
|
6
|
|
Part C
Participants With Cold and Flu
|
42
|
|
Part C
COMPLETED
|
47
|
|
Part C
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Overall Participants
The study consisted of three parts A (includes only healthy participants), B and C (both B and C included healthy and cold and flu participants). Recruitment is done separately for each part of the study, based on the inclusion and exclusion criteria set for the respective part of the study.
|
|---|---|
|
Part A
Withdrawal by Subject
|
1
|
|
Part A
Other (Screening failure)
|
6
|
|
Part A
Other (Survey not completed)
|
3
|
|
Part A
Other (did not completed consent)
|
1
|
|
Part B
Other (Screening failure)
|
10
|
|
Part B
Withdrawal by Subject
|
1
|
|
Part C
Other (Screening failure)
|
1
|
Baseline Characteristics
Motivation, Brain Function and Mood in Individuals With Cold and/or Flu
Baseline characteristics by cohort
| Measure |
Healthy Participants
n=62 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 visual analogue scale (VAS), Cognitive Function Assessment, Reaction time (RTI), Attention switching task (AST), Emotional recognition task (ERT) , Rapid visual information processing (RVP).
|
Participants With Cold and Flu
n=52 Participants
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
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Mean Age
|
34.38 Years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
31.3 Years
STANDARD_DEVIATION 10.98 • n=7 Participants
|
32.91 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Arab
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not collected (Part A participants)
|
46 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GlaxoSmithKline (GSK) is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.
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).
Outcome measures
Outcome data not reported
Adverse Events
Participants With Cold and Flu
Healthy Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER