StressPhase 1NCT04273880
Differences by Sex and Genotype in the Effects of Stress on Executive Functions
A Phase 1 study testing Methylphenidate and Vitamin C in people with Stress, run by University of British Columbia at 1 site in Canada.
Trial summary
The aim of this project is to test the effects of an environmental factor (mild stress) on prefrontal cortex (PFC) and the cognitive functions that depend on PFC (collectively called executive functions [EFs]), and to test our predictions concerning how those effects differ by biological factors (hormones and… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Methylphenidate and Vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteCanada
- Study dates
- 28 Apr 2018to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 20 and 35 years old
Who cannot join
- a neurological impairment or disorder, learning disability, or psychological syndrome that might affect EF performance (such as ADHD)
- inability to understand the task instructions (which are in English), or difficulty hearing the instructions, seeing the stimuli, or executing a manual response.
- a serious adverse event during pregnancy or birth.
- an injury (such as a head injury with loss of consciousness) that might affect EF performance.
- a major trauma that might affect current EFs and stress responsivity
- undue current life stress level
Show all 24Show fewer
- taking any medication that affects thinking, memory, mental clarity, or any other EF ability.
- taking any medication that influences circulating gonadal hormone levels (such as oral contraceptives [birth control pill]).
- having taken such medications within the preceding four months.
- smokers
- use of recreational drugs or consumption of alcohol 24 hours prior to the testing sessions
- women without a period that occurs roughly every month (predicting the onset of the next menses in women who don't have their period monthly is difficult)
- women who are pregnant or who are nursing.
- having the eye problem glaucoma
- having a heart condition
- being anxious, tense or agitated
- taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
- taking pressor agents (for hypotension treatment)
- taking coumarin anticoagulants
- taking anticonvulsants (phenobarbital, diphenylhydantoin, primidone)
- taking phenylbutazone (nonsteroidal anti-inflammatory drug)
- taking tricyclic antidepressants (imipramine, desipramine)
- taking cold or allergy medicine that contain decongestants
- being allergic to anything in either the MPH or Vitamin C capsules (methylphenidate HCL, ascorbic acid, lactose, gelatin, Titanium dioxide, D\&C Red #28, FD\&C Blue #1, FD\&C Red #40)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Developmental Cognitive Neuroscience Lab, Department of Psychiatry, University of British Columbia
Vancouver, British Columbia, V6T 2A1
Daphne Ling, B.Sc. (Hon), 604-827-3074, daphne.ling@ubc.ca
David Abbott, B.Sc. (Hon), 604-827-3074, david.abbott@ubc.ca
About this study
The aim of this project is to test the effects of an environmental factor (mild stress) on prefrontal cortex (PFC) and the cognitive functions that depend on PFC (collectively called executive functions [EFs]), and to test our predictions concerning how those effects differ by biological factors (hormones and genotype). To test our hypotheses concerning mechanism, the investigators will model the effects of mild stress on EFs pharmacologically. The purpose is to pharmacologically model the effects of mild stress on the cognitive functions (collectively called "executive functions" [EFs]) dependent on the frontal lobe. The investigators would also like to investigate how gender differences and genotype mediate the effect of methylphenidate (MPH) on EFs.
Read the detailed description
The investigators propose to test each young adult twice; once on the lowest clinically relevant dose of MPH and once on a placebo (Vitamin C), with the order counterbalanced. The two testing sessions will be scheduled 4 weeks apart, once 90 minutes after taking 10mg MPH and once 90 minutes after taking a placebo (90 mg of Vitamin C). Peak plasma concentration of MPH is reached approximately 2 h after ingestion, thus to gain the maximum effect of MPH, the investigators will test subjects 90 minutes after ingestion. They will tell subjects that they are studying the effects of low-dose MPH on EFs, and that they expect it to help the EFs of some but hinder those of others, without telling them the study's predictions. Before each testing session, subjects will come to the lab 90 minutes in advance of the testing period. First, they will be given a pill they will take in front of a research assistant (MPH or placebo). The conditions will be counterbalanced across subjects within each subject group. This is a double-blind design, where neither subject nor tester will know which condition they will be in. The pills (10mg MPH, and 90mg Vitamin C) are made to be identical. They will be over-encapsulated with an opaque coloured capsule. The pills will be in kept in sealed containers that are labeled in such a way that neither the subjects, nor the testers, nor the PI, will not know which pill is which, until it is time for the data analysis. Only a pharmacist, at the compounding pharmacy, will know which container contains which pill.
At low doses the mode of action of MPH increases DA efflux specifically in PFC and preferentially enhances signal processing in PFC. Low dosages of MPH are often effective in improving EFs and specifically because of their effect on PFC. This slight increase of DA in the PFC is similar to the effects of mild stress on the brain, which is why the study uses a low dose of MPH as the pharmacological model of mild stress. Even mild stress markedly increases DA levels in PFC, impairing PFC function and EFs. The use of MPH is meant to mimic the effect of mild stress on the PFC and executive functions.
Purpose/objective: This double-blind study aims to compare performance on tasks of executive function between males, females when their estrogen levels are high, and females when their estrogen levels are low when they have undergone a pharmacological model of mild stress (low dosage of MPH) and when they have not undergone this stress. It also aims to compare the same across the three variants of the catechol-O-methyltransferase (COMT) genotype (methionine-methionine, methionine-valine, and valine-valine).
Hypotheses: MPH, like mild-stress, should raise PFC DA levels in COMT-Vals to optimal, but raise PFC DA levels in COMT-Mets past optimal (since low dose of MPH increases DA levels in PFC). While COMT-Mets generally show better EFs than COMT-Vals without MPH, on MPH that should be reversed with COMT-Vals performing better. An increase in PFC DA levels pharmacologically should mimic the sex difference in the effect of mild stress on EFs, harming females with high estrogen level's performance while enhancing males' performance on tasks of executive functions.
- Conditions
- Stress
- Being tested
- Methylphenidate, Vitamin C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called 02249324
10mg of MPH taken an hour and a half before one of the testing sessions.
Vitamin CDrug
Also called Ascorbic Acid
90 mg of Vitamin C taken an hour and a half before the other testing session
| Study group | Role | What they receive |
|---|---|---|
| 10 mg Psychostimulant | Experimental | Drug: Methylphenidate (MPH) Participants will be tested twice, approximately one month apart. In one of the sessions, they will be given 10mg of MPH an hour and a half before the testing session is set to begin, to account for the time taken for the effects of the drug to start. Receives: Drug: Methylphenidate |
| 90 mg Vitamin C | Placebo comparator | Placebo: Vitamin C Participants will be tested twice, approximately one month apart. In one of the sessions, they will be given 90mg of Vitamin an hour and a half before the testing session is set to begin, to follow the exact protocol that is used for MPH. Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective attention as assessed by the Flanker/Reverse Flanker task: Day 1
In the regular Flanker task, participants must selectively attend to the direction in which the center stimulus is pointing, ignoring the flanking stimuli. They must press the leftmost key or the rightmost key depending on the direction of the center stimulus. In the Reverse Flanker task, participants must selectively attend to the direction in which the flanking stimulus are pointing, ignoring the center stimulus. Response time and accuracy are measured.
Measured: Day 1
Selective attention as assessed by the Flanker/Reverse Flanker task: 1 Month
In the regular Flanker task, participants must selectively attend to the direction in which the center stimulus is pointing, ignoring the flanking stimuli. They must press the leftmost key or the rightmost key depending on the direction of the center stimulus. In the Reverse Flanker task, participants must selectively attend to the direction in which the flanking stimulus are pointing, ignoring the center stimulus. Response time and accuracy are measured.
Measured: 1 Month
Working memory as assessed by the N-back task: Day 1
In the N-back task, participants must watch a series of letters flash on screen and press the left mouse button whenever the stimulus that appeared was the same as the stimulus that appeared one stimulus prior (e.g. "A, J, A" - press at the second "A"). Response time and accuracy are measured in both tasks.
Measured: Day 1
Working memory as assessed by the N-back task: 1 Month
In the N-back task, participants must watch a series of letters flash on screen and press the left mouse button whenever the stimulus that appeared was the same as the stimulus that appeared one stimulus prior (e.g. "A, J, A" - press at the second "A"). Response time and accuracy are measured in both tasks.
Measured: 1 Month
Working memory as assessed by the Forward Re-Ordering Digit Span task: Day 1
In the Forward Re-Ordering Digit Span task, participants listen to a series of numbers read out by the tester and they must verbally re-order the numbers in the forward direction. Response time and accuracy are measured in both tasks.
Measured: Day 1
Working memory as assessed by the Forward Re-Ordering Digit Span task: 1 Month
In the Forward Re-Ordering Digit Span task, participants listen to a series of numbers read out by the tester and they must verbally re-order the numbers in the forward direction. Response time and accuracy are measured in both tasks.
Measured: 1 Month
Inhibition as assessed by the Hearts & Flowers task: Day 1
On the first block of the Hearts \& Flowers task, participants must press the button on the same side as a stimulus (e.g. a heart). Then, on the second block, they must press the button on the opposite side as a stimulus (e.g. a flower). Response time and accuracy are measured.
Measured: Day 1
Inhibition as assessed by the Hearts & Flowers task: 1 Month
On the first block of the Hearts \& Flowers task, participants must press the button on the same side as a stimulus (e.g. a heart). Then, on the second block, they must press the button on the opposite side as a stimulus (e.g. a flower). Response time and accuracy are measured.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start28 Apr 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Adele Diamond, University of British Columbia
- Investigators
- Adele Diamond, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273880
- Sponsor's protocol ID
- H13-00286
- Other IDs
- 5R01DA037285-05
- Status last verified
- May 2024
- First submitted
- 27 May 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed at the group level
Publications
Arnsten AF, Goldman-Rakic PS. Noise stress impairs prefrontal cortical cognitive function in monkeys: evidence for a hyperdopaminergic mechanism. Arch Gen Psychiatry. 1998 Apr;55(4):362-8. doi: 10.1001/archpsyc.55.4.362.
PubMed 9554432Barkley, R. A. (2001). The inattentive type of ADHD as a distinct disorder: What remains to be done. Clinical Psychology: Science and Practice, 8, 489-493.
Barkley RA, DuPaul GJ, McMurray MB. Attention deficit disorder with and without hyperactivity: clinical response to three dose levels of methylphenidate. Pediatrics. 1991 Apr;87(4):519-31.
PubMed 2011430Berridge CW, Devilbiss DM, Andrzejewski ME, Arnsten AF, Kelley AE, Schmeichel B, Hamilton C, Spencer RC. Methylphenidate preferentially increases catecholamine neurotransmission within the prefrontal cortex at low doses that enhance cognitive function. Biol Psychiatry. 2006 Nov 15;60(10):1111-20. doi: 10.1016/j.biopsych.2006.04.022. Epub 2006 Jun 23.
PubMed 16806100Cerqueira JJ, Mailliet F, Almeida OF, Jay TM, Sousa N. The prefrontal cortex as a key target of the maladaptive response to stress. J Neurosci. 2007 Mar 14;27(11):2781-7. doi: 10.1523/JNEUROSCI.4372-06.2007.
PubMed 17360899Devilbiss DM, Berridge CW. Cognition-enhancing doses of methylphenidate preferentially increase prefrontal cortex neuronal responsiveness. Biol Psychiatry. 2008 Oct 1;64(7):626-35. doi: 10.1016/j.biopsych.2008.04.037. Epub 2008 Jun 30.
PubMed 18585681Dickerson SS, Kemeny ME. Acute stressors and cortisol responses: a theoretical integration and synthesis of laboratory research. Psychol Bull. 2004 May;130(3):355-91. doi: 10.1037/0033-2909.130.3.355.
PubMed 15122924Elliott R, Sahakian BJ, Matthews K, Bannerjea A, Rimmer J, Robbins TW. Effects of methylphenidate on spatial working memory and planning in healthy young adults. Psychopharmacology (Berl). 1997 May;131(2):196-206. doi: 10.1007/s002130050284.
PubMed 9201809Lataster J, Collip D, Ceccarini J, Haas D, Booij L, van Os J, Pruessner J, Van Laere K, Myin-Germeys I. Psychosocial stress is associated with in vivo dopamine release in human ventromedial prefrontal cortex: a positron emission tomography study using [(1)(8)F]fallypride. Neuroimage. 2011 Oct 15;58(4):1081-9. doi: 10.1016/j.neuroimage.2011.07.030. Epub 2011 Jul 23.
PubMed 21801840Milich, R., Balentine, A. C., & Lynam, D. R. (2001). ADHD combined type and ADHD predominantly inattentive type are distinct and unrelated disorders. Clinical Psychology: Science and Practice, 8, 463-488.
Morrow BA, Roth RH, Elsworth JD. TMT, a predator odor, elevates mesoprefrontal dopamine metabolic activity and disrupts short-term working memory in the rat. Brain Res Bull. 2000 Aug;52(6):519-23. doi: 10.1016/s0361-9230(00)00290-2.
PubMed 10974491Roth RH, Tam SY, Ida Y, Yang JX, Deutch AY. Stress and the mesocorticolimbic dopamine systems. Ann N Y Acad Sci. 1988;537:138-47. doi: 10.1111/j.1749-6632.1988.tb42102.x. No abstract available.
PubMed 3059920Schmeichel BE, Zemlan FP, Berridge CW. A selective dopamine reuptake inhibitor improves prefrontal cortex-dependent cognitive function: potential relevance to attention deficit hyperactivity disorder. Neuropharmacology. 2013 Jan;64(1):321-8. doi: 10.1016/j.neuropharm.2012.07.005. Epub 2012 Jul 11.
PubMed 22796428Spencer RC, Klein RM, Berridge CW. Psychostimulants act within the prefrontal cortex to improve cognitive function. Biol Psychiatry. 2012 Aug 1;72(3):221-7. doi: 10.1016/j.biopsych.2011.12.002. Epub 2011 Dec 29.
PubMed 22209638Weiss M, Worling D, Wasdell M. A chart review study of the inattentive and combined types of ADHD. J Atten Disord. 2003 Sep;7(1):1-9. doi: 10.1177/108705470300700101.
PubMed 14738177
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences by Sex and Genotype in the Effects of Stress on Executive Functions
- ClinicalTrials.gov ID
- NCT04273880
- Acronym / sponsor ID
- H13-00286
- Conditions
- Stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 28 Apr 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to test the effects of an environmental factor (mild stress) on prefrontal cortex (PFC) and the cognitive functions that depend on PFC (collectively called executive functions [EFs]), and to test our predictions concerning how those effects differ by biological factors (hormones and genotype). To test our hypotheses concerning mechanism, the investigators will model the effects of mild stress on EFs pharmacologically. The purpose is to pharmacologically model the effects of mild stress on the cognitive functions (collectively called "executive functions" [EFs]) dependent on the frontal lobe. The investigators would also like to investigate how gender differences and genotype mediate the effect of methylphenidate (MPH) on EFs.
Detailed description
The investigators propose to test each young adult twice; once on the lowest clinically relevant dose of MPH and once on a placebo (Vitamin C), with the order counterbalanced. The two testing sessions will be scheduled 4 weeks apart, once 90 minutes after taking 10mg MPH and once 90 minutes after taking a placebo (90 mg of Vitamin C). Peak plasma concentration of MPH is reached approximately 2 h after ingestion, thus to gain the maximum effect of MPH, the investigators will test subjects 90 minutes after ingestion. They will tell subjects that they are studying the effects of low-dose MPH on EFs, and that they expect it to help the EFs of some but hinder those of others, without telling them the study's predictions. Before each testing session, subjects will come to the lab 90 minutes in advance of the testing period. First, they will be given a pill they will take in front of a research assistant (MPH or placebo). The conditions will be counterbalanced across subjects within each subject group. This is a double-blind design, where neither subject nor tester will know which condition they will be in. The pills (10mg MPH, and 90mg Vitamin C) are made to be identical. They will be over-encapsulated with an opaque coloured capsule. The pills will be in kept in sealed containers that are labeled in such a way that neither the subjects, nor the testers, nor the PI, will not know which pill is which, until it is time for the data analysis. Only a pharmacist, at the compounding pharmacy, will know which container contains which pill.
At low doses the mode of action of MPH increases DA efflux specifically in PFC and preferentially enhances signal processing in PFC. Low dosages of MPH are often effective in improving EFs and specifically because of their effect on PFC. This slight increase of DA in the PFC is similar to the effects of mild stress on the brain, which is why the study uses a low dose of MPH as the pharmacological model of mild stress. Even mild stress markedly increases DA levels in PFC, impairing PFC function and EFs. The use of MPH is meant to mimic the effect of mild stress on the PFC and executive functions.
Purpose/objective: This double-blind study aims to compare performance on tasks of executive function between males, females when their estrogen levels are high, and females when their estrogen levels are low when they have undergone a pharmacological model of mild stress (low dosage of MPH) and when they have not undergone this stress. It also aims to compare the same across the three variants of the catechol-O-methyltransferase (COMT) genotype (methionine-methionine, methionine-valine, and valine-valine).
Hypotheses: MPH, like mild-stress, should raise PFC DA levels in COMT-Vals to optimal, but raise PFC DA levels in COMT-Mets past optimal (since low dose of MPH increases DA levels in PFC). While COMT-Mets generally show better EFs than COMT-Vals without MPH, on MPH that should be reversed with COMT-Vals performing better. An increase in PFC DA levels pharmacologically should mimic the sex difference in the effect of mild stress on EFs, harming females with high estrogen level's performance while enhancing males' performance on tasks of executive functions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mg Psychostimulant | Experimental | Drug: MethylphenidateDrug: Methylphenidate (MPH) Participants will be tested twice, approximately one month apart. In one of the sessions, they will be given 10mg of MPH an hour and a half before the testing session is set to begin, to account for the time taken for the effects of the drug to start. |
| 90 mg Vitamin C | Placebo comparator | Drug: Vitamin CPlacebo: Vitamin C Participants will be tested twice, approximately one month apart. In one of the sessions, they will be given 90mg of Vitamin an hour and a half before the testing session is set to begin, to follow the exact protocol that is used for MPH. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Between the ages of 20 and 35 years old
Key exclusion criteria (24 listed)
- a neurological impairment or disorder, learning disability, or psychological syndrome that might affect EF performance (such as ADHD)
- inability to understand the task instructions (which are in English), or difficulty hearing the instructions, seeing the stimuli, or executing a manual response.
- a serious adverse event during pregnancy or birth.
- an injury (such as a head injury with loss of consciousness) that might affect EF performance.
- a major trauma that might affect current EFs and stress responsivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: 0224932410mg of MPH taken an hour and a half before one of the testing sessions. | Drug | 10 mg Psychostimulant |
| Vitamin CAlso: Ascorbic Acid90 mg of Vitamin C taken an hour and a half before the other testing session | Drug | 90 mg Vitamin C |
Primary outcome
Selective attention as assessed by the Flanker/Reverse Flanker task: Day 1
Time frame: Day 1
In the regular Flanker task, participants must selectively attend to the direction in which the center stimulus is pointing, ignoring the flanking stimuli. They must press the leftmost key or the rightmost key depending on the direction of the center stimulus. In the Reverse Flanker task, participants must selectively attend to the direction in which the flanking stimulus are pointing, ignoring the center stimulus. Response time and accuracy are measured.
Selective attention as assessed by the Flanker/Reverse Flanker task: 1 Month
Time frame: 1 Month
In the regular Flanker task, participants must selectively attend to the direction in which the center stimulus is pointing, ignoring the flanking stimuli. They must press the leftmost key or the rightmost key depending on the direction of the center stimulus. In the Reverse Flanker task, participants must selectively attend to the direction in which the flanking stimulus are pointing, ignoring the center stimulus. Response time and accuracy are measured.
Working memory as assessed by the N-back task: Day 1
Time frame: Day 1
In the N-back task, participants must watch a series of letters flash on screen and press the left mouse button whenever the stimulus that appeared was the same as the stimulus that appeared one stimulus prior (e.g. "A, J, A" - press at the second "A"). Response time and accuracy are measured in both tasks.
Working memory as assessed by the N-back task: 1 Month
Time frame: 1 Month
In the N-back task, participants must watch a series of letters flash on screen and press the left mouse button whenever the stimulus that appeared was the same as the stimulus that appeared one stimulus prior (e.g. "A, J, A" - press at the second "A"). Response time and accuracy are measured in both tasks.
Working memory as assessed by the Forward Re-Ordering Digit Span task: Day 1
Time frame: Day 1
In the Forward Re-Ordering Digit Span task, participants listen to a series of numbers read out by the tester and they must verbally re-order the numbers in the forward direction. Response time and accuracy are measured in both tasks.
Working memory as assessed by the Forward Re-Ordering Digit Span task: 1 Month
Time frame: 1 Month
In the Forward Re-Ordering Digit Span task, participants listen to a series of numbers read out by the tester and they must verbally re-order the numbers in the forward direction. Response time and accuracy are measured in both tasks.
Inhibition as assessed by the Hearts & Flowers task: Day 1
Time frame: Day 1
On the first block of the Hearts \& Flowers task, participants must press the button on the same side as a stimulus (e.g. a heart). Then, on the second block, they must press the button on the opposite side as a stimulus (e.g. a flower). Response time and accuracy are measured.
Inhibition as assessed by the Hearts & Flowers task: 1 Month
Time frame: 1 Month
On the first block of the Hearts \& Flowers task, participants must press the button on the same side as a stimulus (e.g. a heart). Then, on the second block, they must press the button on the opposite side as a stimulus (e.g. a flower). Response time and accuracy are measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 9554432Arnsten AF, Goldman-Rakic PS. Noise stress impairs prefrontal cortical cognitive function in monkeys: evidence for a hyperdopaminergic mechanism. Arch Gen Psychiatry. 1998 Apr;55(4):362-8. doi: 10.1001/archpsyc.55.4.362.
- BackgroundBarkley, R. A. (2001). The inattentive type of ADHD as a distinct disorder: What remains to be done. Clinical Psychology: Science and Practice, 8, 489-493.
- Background: PubMed 2011430Barkley RA, DuPaul GJ, McMurray MB. Attention deficit disorder with and without hyperactivity: clinical response to three dose levels of methylphenidate. Pediatrics. 1991 Apr;87(4):519-31.
- Background: PubMed 16806100Berridge CW, Devilbiss DM, Andrzejewski ME, Arnsten AF, Kelley AE, Schmeichel B, Hamilton C, Spencer RC. Methylphenidate preferentially increases catecholamine neurotransmission within the prefrontal cortex at low doses that enhance cognitive function. Biol Psychiatry. 2006 Nov 15;60(10):1111-20. doi: 10.1016/j.biopsych.2006.04.022. Epub 2006 Jun 23.
- Background: PubMed 17360899Cerqueira JJ, Mailliet F, Almeida OF, Jay TM, Sousa N. The prefrontal cortex as a key target of the maladaptive response to stress. J Neurosci. 2007 Mar 14;27(11):2781-7. doi: 10.1523/JNEUROSCI.4372-06.2007.
- Background: PubMed 18585681Devilbiss DM, Berridge CW. Cognition-enhancing doses of methylphenidate preferentially increase prefrontal cortex neuronal responsiveness. Biol Psychiatry. 2008 Oct 1;64(7):626-35. doi: 10.1016/j.biopsych.2008.04.037. Epub 2008 Jun 30.
- Background: PubMed 15122924Dickerson SS, Kemeny ME. Acute stressors and cortisol responses: a theoretical integration and synthesis of laboratory research. Psychol Bull. 2004 May;130(3):355-91. doi: 10.1037/0033-2909.130.3.355.
- Background: PubMed 9201809Elliott R, Sahakian BJ, Matthews K, Bannerjea A, Rimmer J, Robbins TW. Effects of methylphenidate on spatial working memory and planning in healthy young adults. Psychopharmacology (Berl). 1997 May;131(2):196-206. doi: 10.1007/s002130050284.
- Background: PubMed 21801840Lataster J, Collip D, Ceccarini J, Haas D, Booij L, van Os J, Pruessner J, Van Laere K, Myin-Germeys I. Psychosocial stress is associated with in vivo dopamine release in human ventromedial prefrontal cortex: a positron emission tomography study using [(1)(8)F]fallypride. Neuroimage. 2011 Oct 15;58(4):1081-9. doi: 10.1016/j.neuroimage.2011.07.030. Epub 2011 Jul 23.
- BackgroundMilich, R., Balentine, A. C., & Lynam, D. R. (2001). ADHD combined type and ADHD predominantly inattentive type are distinct and unrelated disorders. Clinical Psychology: Science and Practice, 8, 463-488.
- Background: PubMed 10974491Morrow BA, Roth RH, Elsworth JD. TMT, a predator odor, elevates mesoprefrontal dopamine metabolic activity and disrupts short-term working memory in the rat. Brain Res Bull. 2000 Aug;52(6):519-23. doi: 10.1016/s0361-9230(00)00290-2.
- Background: PubMed 3059920Roth RH, Tam SY, Ida Y, Yang JX, Deutch AY. Stress and the mesocorticolimbic dopamine systems. Ann N Y Acad Sci. 1988;537:138-47. doi: 10.1111/j.1749-6632.1988.tb42102.x. No abstract available.
- Individual participant dataSharing planned: No. Data will be analyzed at the group level
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Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adele Diamond, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methylphenidate and Vitamin C in people with Stress, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daphne Ling, BSc (6048273074, daphne.ling@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective attention as assessed by the Flanker/Reverse Flanker task: Day 1 (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273880, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.