Recruiting
Phase 1

Observational Study

Sponsor:

University of British Columbia

Code:

NCT04273880

Conditions

Stress

Eligibility Criteria

Sex: All

Age: 20 - 35

Healthy Volunteers: Accepted

Interventions

Methylphenidate

Vitamin C

Study Details

Brief 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 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.

Conditions

Stress

Study ID

NCT04273880

Start date

Apr 28, 2018

Status verified date

May, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 35

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

146 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 10 mg Psychostimulant

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.

placebo comparator: 90 mg Vitamin C

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.

Interventions

Methylphenidate

10mg of MPH taken an hour and a half before one of the testing sessions.

Vitamin C

90 mg of Vitamin C taken an hour and a half before the other testing session

Primary outcome measure

  • Selective attention as assessed by the Flanker/Reverse Flanker task: Day 1 [ Time Frame: Day 1 ]
  • Selective attention as assessed by the Flanker/Reverse Flanker task: 1 Month [ Time Frame: 1 Month ]
  • Working memory as assessed by the N-back task: Day 1 [ Time Frame: Day 1 ]
  • Working memory as assessed by the N-back task: 1 Month [ Time Frame: 1 Month ]
  • Working memory as assessed by the Forward Re-Ordering Digit Span task: Day 1 [ Time Frame: Day 1 ]
  • Working memory as assessed by the Forward Re-Ordering Digit Span task: 1 Month [ Time Frame: 1 Month ]
  • Inhibition as assessed by the Hearts & Flowers task: Day 1 [ Time Frame: Day 1 ]
  • Inhibition as assessed by the Hearts & Flowers task: 1 Month [ Time Frame: 1 Month ]

Central Contacts and Locations

Central contacts

Daphne Ling, BSc

6048273074daphne.ling@ubc.ca

David Abbott, BSc

6048273074david.abbott@ubc.ca

Locations

Developmental Cognitive Neuroscience Lab, Department of Psychiatry, University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6T 2A1

Contacts

Daphne Ling, B.Sc. (Hon)

604-827-3074daphne.ling@ubc.ca

David Abbott, B.Sc. (Hon)

604-827-3074david.abbott@ubc.ca

Principal Investigator:

Adele Diamond, Ph.D.

More Information

Sponsor

University of British Columbia

Last update posted

May 8, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-05-08.