Last updated: 11/03/2018 23:27:22
Motivation, brain function and mood in individuals with cold and/or flu
GSK study ID
205689
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: Effects of cold and/or flu on motivation, mood and cognitive performance in otherwise healthy individuals
Trial description: 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 ingeneral motivation, 2) change in cold and flu-specific motivation, and 3) any change in general tendency to exert force to serve as a control.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Liking rating on 11 point Likert scale (0-10 – 0 = Not at all; 10 = Like Extremely)
Timeframe: At Screening
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
Change in Emotional recognition task (ERT) score (number of total hits) in participants suffering from cold and flu versus healthy participants
Timeframe: Day 1
Change in Rapid Visual Information Processing (RVP) A Prime (RVP A’) in participants suffering from cold and flu versus healthy participants
Timeframe: Day 1
Change in Attention switching task (AST) score (congruency cost [ms]) in participants suffering from cold and flu versus healthy participants
Timeframe: Day 1
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:
Not applicable
Interventions:
Behavioral: Participants self-administered questionnaire and assessment
Enrollment:
114
Observational study model:
Not applicable
Primary completion date:
2016-24-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cognition
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2016 to November 2016
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- 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.
- 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).
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
Brentford, Middlesex, United Kingdom, TW8 9DA
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2016-24-11
Actual study completion date
2016-24-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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