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Stress Management for Cognitive Function

Phase 1

Recruiting

Led By Adele Diamond, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 20 and 35 years old

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Study Summary

This trial is testing the effects of stress on the cognitive functions that depend on the prefrontal cortex, as well as how different genders and genotypes mediate the effect of methylphenidate on these functions.

Who is the study for?

This trial is for adults aged 20-35 who can understand English instructions and are not affected by conditions that impair cognitive functions. It excludes pregnant or nursing women, those with irregular menstrual cycles, glaucoma, anxiety disorders, recent MAOI antidepressant use, hypotension treatment with pressor agents, allergy to trial medications' ingredients, life stressors affecting cognition or hormone levels (e.g., oral contraceptives), smokers, heart conditions patients and those with neurological issues.Check my eligibility

What is being tested?

The study examines how mild stress affects executive functions reliant on the frontal lobe of the brain. It will also explore gender differences and genetic factors in response to Vitamin C and Methylphenidate (a stimulant medication). Participants will be tested under mildly stressful conditions to see how these interventions impact their cognitive performance.See study design

What are the potential side effects?

Potential side effects from Methylphenidate include nervousness, trouble sleeping and loss of appetite. High doses might cause more serious side effects like increased blood pressure or irregular heartbeat. Vitamin C is generally well-tolerated but may cause digestive discomfort at high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 20 and 35 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Inhibition as assessed by the Hearts & Flowers task: 1 Month

Inhibition as assessed by the Hearts & Flowers task: Day 1

Selective attention as assessed by the Flanker/Reverse Flanker task: 1 Month

+5 more

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908

51%

Appetite Loss

40%

Insomnia

33%

Irritability

29%

Picking at skin, nailbiting

21%

Worried/Anxious

21%

Dull, tired, listless

19%

Tearful, depressed

18%

Stomachache

13%

Headache

13%

Motor Tics

12%

Buccal-lingual movements

10%

Social Withdrawal

Hospitalized

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1 - Placebo First

Phase 1-Medication First

Phase 2 - 7-Day Dosing

Phase 2 - 5-Day Dosing

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 10 mg PsychostimulantExperimental Treatment1 Intervention

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.

Group II: 90 mg Vitamin CPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylphenidate

2014

Completed Phase 4

~431850

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,584 Total Patients Enrolled

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,972 Total Patients Enrolled

Adele Diamond, PhDPrincipal InvestigatorUniversity of British Columbia

1 Previous Clinical Trials

108 Total Patients Enrolled

Media Library

Mild Stress (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04273880 — Phase 1

Stress Research Study Groups: 90 mg Vitamin C, 10 mg Psychostimulant

Stress Clinical Trial 2023: Mild Stress Highlights & Side Effects. Trial Name: NCT04273880 — Phase 1

Mild Stress (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04273880 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots remaining for potential participants in this clinical experiment?

"Affirmative, the information available on clinicaltrials.gov suggests that this ongoing trial is still enrolling participants. It was initially posted on April 28th 2018 and last updated May 16th 2022; seeking to enrol 146 individuals at a single medical centre."

Answered by AI

Does this research accept individuals aged 65 and older?

"This medical experiment requires that patients enrolled are aged between 20 and 35. An additional 32 studies have been conducted on individuals below the age of 18, with 164 being available for those over 65."

Answered by AI

Who qualifies to take part in this research endeavor?

"This trial seeks 146 participants who suffer from stress, ranging in age between 20 and 35. To be considered for admission, these criteria must be met."

Answered by AI

How many participants is the clinical trial enrolling?

"Affirmative. Records hosted on clinicaltrials.gov demonstrate that this experiment is presently enrolling patients, having been posted on April 28th 2018 and most recently revised May 16th 2022. Approximately 146 individuals are needed for the study to take place at a single site."

Answered by AI

What consequences are associated with the utilization of Methylphenidate?

"As Phase 1 trials typically provide limited evidence of safety and efficacy, our team at Power assigned Methylphenidate a score of one on their risk assessment scale."

Answered by AI