Effects of mild stress on cognitive functions and how they differ by sex and genotype
Differences by Sex and Genotype in the Effects of Stress on Executive Functions
This study is testing how mild stress affects thinking skills in young adults, looking at differences based on sex and genetics, while using a medication and a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT04273880 on ClinicalTrials.gov |
What this trial studies
This project aims to investigate how mild stress impacts executive functions, which are cognitive processes dependent on the prefrontal cortex. The study will involve young adults who will participate in two testing sessions, one after taking a low dose of methylphenidate (MPH) and another after a placebo (Vitamin C), with the order of sessions counterbalanced. The researchers will analyze the effects of these interventions on executive functions while considering biological factors such as sex and genotype. The study employs a double-blind design to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy young adults aged 20 to 35 without neurological impairments or psychological disorders.
Not a fit: Patients with neurological disorders, learning disabilities, or those currently experiencing undue life stress may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how stress affects cognitive functions, potentially leading to better management strategies for stress-related cognitive impairments.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown that pharmacological interventions can influence cognitive functions under stress.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Between the ages of 20 and 35 years old Exclusion Criteria: * 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 * 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)
Where this trial is running
Vancouver, British Columbia
- Developmental Cognitive Neuroscience Lab, Department of Psychiatry, University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Adele Diamond, PhD — University of British Columbia
- Study coordinator: Daphne Ling, BSc
- Email: daphne.ling@ubc.ca
- Phone: 6048273074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.