Stimulant Effects on Brain Activity

NCT02453698 | Completed Phase 1

• 1 other identifier: 1000020845
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of Methylphenidate on neural activity underlying inhibitory control and error monitoring in healthy adults. More specifically, the investigators aim to establish the baseline modulatory effect of Mehtlylphenidate on bottom-up and top-down aspects of these cognitive processes. This work will further our understanding of Attention Deficit Hyperactivity Disorder, Methylphenidate, and executive functioning.

Conditions

Healthy Volunteers

Keywords

Stop task; modulatory effect of MPH; bottom-up and top-down; cognitive processes

Outcome Measures

Primary Outcomes (1)

• Neural activity assessed using fMRI

  Assessed using fMRI

  7 days

Study Arms (2)

Methylphenidate

EXPERIMENTAL

Drug: Methylphenidate

Control Group

PLACEBO COMPARATOR

Other: Placebo

Interventions

Methylphenidate DRUG

oral dose of methylphenidate. The MPH dose was selected based on previous studies in healthy adults (Mehta et al., 2000; Volkow, Fowler, Wang, Ding, \& Gatley, 2002) and adults with ADHD (Aron et al., 2003). MPH reaches its peak plasma concentration 1-3 hours after an oral dose, and has a plasma half-life of 1.5-2.5 hours.

Methylphenidate

Placebo OTHER

Lactose Placebo

Control Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non-smoking, male and female volunteers, between 18 to 35 years of age inclusive, right-handed
• Body Mass Index that is within 18.5-29.9 kg/m2, inclusive
• Healthy, according to the medical history, vital signs, and physical examination (within 2 years prior to study enrollment)
• Systolic blood pressure between 100-140 mmHg, inclusive, and diastolic blood pressure between 60-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed not clinically significant by the Principal Investigator/ Sub-Investigator?
• Capable of giving written informed consent prior to receiving any study medication
• Female subjects must fulfill at least one of the following:
• Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior to the study, during the study, and until 30 days after the study has ended (last study procedure). Medically acceptable methods of contraception include oral contraceptives, hormonal patch, implant or injection intrauterine device, or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide). Complete abstinence alone can be used as a method of contraception.
• Be surgically sterile for a minimum of 6 months
• Post-menopausal for a minimum of 1 year

You may not qualify if:

• Known history or presence of any clinically significant hepatic (e.g. hepatic necrosis, jaundice, hepatobiliary disease), renal, gastrointestinal (e.g. peptic ulcer), cardiovascular (e.g. angina, myocardial infarction), cerebrovascular, pulmonary, endocrine (e.g. diabetes, hypophosphatemia), immunological, musculoskeletal (e.g. rhabdomyolysis, myopathy), neurological, psychiatric, dermatological, or hematological disease or condition
• Presence of any clinically significant illness within 30 days prior to dosing
• Presence of any significant physical or organ abnormality
• Known history or presence of:
• Alcohol abuse or dependence within one year prior to drug administration
• Drug abuse or dependence
• Hypersensitivity to methylphenidate or other medications
• Gout
• Food allergies and/or presence of any dietary restrictions
• Severe allergic reactions (e.g. anaphylactic reactions, angioedema)
• Participation in another clinical trial or receiving an investigational drug within 30 days of the study commencement or during the study
• Use of any prescription medication within 14 days prior to drug administration (except for hormonal contraceptives)
• Use of any over-the-counter medications (including herbal and/or dietary supplements and/or teas) within 14 days prior to drug administration (except for spermicidal/barrier contraceptive products)
• Any major surgery within 6 months prior to the start of the study
• Pregnant or lactating

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

Methylphenidate

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Russell Schachar, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 25, 2015
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

CA (1)