Attention Deficit Hyperactivity DisordersPhase 1/2NCT02167048
Low-dose vs. Normal-dose Psychostimulants on Executive Functions in Individuals With ADHD
A Phase 1/2 study testing Psychostimulants in people with Attention Deficit Hyperactivity Disorders, run by University of British Columbia at 1 site in Canada.
Trial summary
This double-blind crossover study aims to compare cognitive performance (e.g., working memory, selective attention and cognitive flexibility) of children ages 6-18 years diagnosed with ADHD of the combined type (ADHD-C) or inattentive-type (ADHD-IA) and currently on > 20 mg/day of psychostimulants (psychostimulants)… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorders
- What is being tested?
- Psychostimulants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Dec 2024
- Phase
- Phase 1/2
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between the chronological ages of 6 and 18 years
- Average to above-average IQ (Parental report of an IQ above 90; we will take their word for it)
- Meet DSM-V criteria for ADHD (Combined type or Inattentive type)
- Currently treated with and responding to oral Psychostimulants >= 20 mg/day and not on a "drug holiday"
- Stable on current Psychostimulant dose for at least 2 weeks
- Able to communicate (understand, speak, and write) in English without the aid of an interpreter
- Able to execute simple manual response (button-press) as required for our tasks
- The child and parent give assent and consent respectively for the child's participation in this study
Who cannot join
- Patients with significant prior or current medical conditions that could impact neuropsychological performance such as traumatic brain injury, hypoxia, or unstable diabetes.
- Have any medical condition that could markedly increase sympathetic nervous system activity (e.g. catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (e.g. pseudoephedrine, oral steroids) that has sympathomimetic activity. Note: regular on-label use of inhalers for asthma (e.g., albuterol, steroidal) is permitted
- Taking any psychotropic medication other than on-label Psychostimulants specifically prescribed to treat ADHD
- Have a major, uncorrected sensory impairment (e.g. significant hearing impairment despite hearing aids)
- Lack sufficient English language skills to perform our tasks
- Are taking medications other than their specifically prescribed Psychostimulants that may affect cognitive skills
Show all 10Show fewer
- Have a documented history of Dyslexia (this may skew results on our cognitive measures), Bipolar I or II, psychosis, Depression, Autism Spectrum Disorders, or Disruptive Mood Dysregulation Disorder
- Have a past history of any severe adverse reaction to lowering of Psychostiumlant dose
- Patient has been non-compliant with Psychostimulants or is on a "drug holiday"
- Parental report of an IQ below 90 (we will take their word for it)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Developmental Cognitive Neuroscience Lab, Department of Psychiatry, University of British Columbia
Vancouver, British Columbia, V6T 2A1
About this study
Official title: Effects of Low-dose Versus Normal-dose Psychostimulants on Executive Functions in Individuals With Attention-Deficit Hyperactivity Disorder
This double-blind crossover study aims to compare cognitive performance (e.g., working memory, selective attention and cognitive flexibility) of children ages 6-18 years diagnosed with ADHD of the combined type (ADHD-C) or inattentive-type (ADHD-IA) and currently on > 20 mg/day of psychostimulants (psychostimulants) on: a) their current dose of psychostimulants, vs. b) a lower-dose of psychostimulants (half of their current dose).
The investigators hypothesize that the lower-dose psychostimulants will result in better cognitive performance than moderate-to-high doses of psychostimulants.
Read the detailed description
Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by attention deficits, hyperactivity, or impulsive actions that are not appropriate for the individuals' age (Barkley 1997). These behavioural issues arise relatively early in life, typically before the age of 12, and continue to persist into adulthood in many cases (Barkley 1997). In school-aged children, ADHD is associated with low academic achievement, poor school performance, anxiety and depression.
Symptoms are divided into inattention (e.g., easily distracted, difficulty focusing on \& completing a task), hyperactivity (e.g., constantly in motion, fidgets, squirms, talks non-stop), and impulsivity (e.g., difficult waiting one's turn, interrupting others). Three subtypes of ADHD have been identified: predominantly inattentive (ADHD-I), predominantly hyperactive-impulsive (ADHD-H), and the combined type (ADHD-C).
Psychostimulants in medium to high doses acts to inhibit re-uptake of dopamine by the dopamine transporter (DAT), resulting in increased dopamine concentrations in the synapse. DAT is abundant in the striatum, which is implicated in hyperactivity and impulsivity aspects of ADHD. However, DAT is sparse in prefrontal cortex (PFC), which plays a critical role in subserving executive functions. Executive functions (EFs; also called cognitive control or self-regulation) are a group of processes involved in concentration, focused attention, self-control, cognitive flexibility, problem-solving, and working memory (refs: Diamond, 2013; Jacques \& Marcovitch, 2010). Thus the number of high risk alleles of the gene that codes for the dopamine transporter (DAT1) are associated with hyperactivity (which depends on the striatum) but not inattention or EF deficits (which depend on PFC; refs: Jucaite et al., 2005; Waldman et al., 1998.
The action of low doses of psychostimulants has been shown to be different, however. At low doses psychostimulants has been demonstrated to act preferentially on PFC, increasing dopamine release (refs: Berridge et al., 2006; Schmeichel \& Berridge, 2013; Spencer et al, 2012). Thus, moderate to high doses of psychostimulants (doses most often prescribed for children and youths with ADHD) probably do not improve PFC function or EFs, or worse, may actually impair cognitive function, leaving a patient feeling more in a daze.
Optimal dosing for psychostimulants in children and youths with ADHD is usually determined by parents' reports of improved behaviour, almost never by performance on cognitive measures. We propose to look at cognitive performance on measures of attention, working memory, planning, etc. in children and youths with ADHD on their current dose of psychostimulants and on half that much (order counterbalanced across participants).
Purpose/Objectives: This double-blind crossover study aims to compare cognitive performance (e.g., working memory, selective attention and cognitive flexibility) of children ages 6-18 years diagnosed with ADHD of the combined type (ADHD-C) or inattentive-type (ADHD-IA) and currently on > 20 mg/day of psychostimulants on their current dose of psychostimulants and on a lower-dose of psychostimulants (half of their current dose), order counterbalanced across subjects.
To give us an estimate of order effects to help us correct for better performance in the 2nd session due simply to taking the same cognitive tests twice (note: the tests are Version A and B), we will also be recruiting healthy volunteers to serve as a control group. This control group will be strictly no intervention.
Hypotheses: The investigators hypothesize that lower-dose psychostimulants will result in better cognitive performance than moderate-to-high doses of psychostimulants.
- Being tested
- Psychostimulants
- Keywords
- Attention Deficit Hyperactivity Disorders, Executive Function, Methylphenidate, Psychostimulants, Adolescent, Child, Working Memory, Prefrontal Cortex, Attention, Cognitive Function, Inhibition
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychostimulantsDrug
Participants will be tested twice 2 weeks apart. All will continue on their normal Psychostimulant dose up until 3 days before the testing day. 3 days before their 1st testing session, half the participants will start on either their current-dose of Psychostimulant or half their current dose depending on the arm they were randomized to (we provide those pills).
To control for different pharmacokinetics of the Psychostimulant medications, a given participant will be tested at roughly the peak time for his/her specific version of Psychostimulant and at the same time of day for his/her two testing sessions.
| Study group | Role | What they receive |
|---|---|---|
| Normal-dose Psychostimulant, Low-dose | Experimental | Normal-dose: Dose participants are currently taking as part of their prescription (on more than or equals to 20 mg/day of Psychostimulants) Low-dose: Half the normal dose Receives: Drug: Psychostimulants |
| Low-dose Psychostimulants, Normal-dose | Active comparator | Normal-dose: Dose participants are currently taking as part of their prescription (on more than or equals to 20 mg/day of Psychostimulants) Low-dose: Half the normal dose Receives: Drug: Psychostimulants |
| No intervention, No intervention | No intervention | This arm is completely no intervention, and is ONLY for healthy volunteers. We are testing healthy volunteers of the same age to give us an estimate of order effects to help us correct for better performance in the 2nd session due simply to taking the same tests twice (note: the tests are Version A and B). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Functions (difference in performance on the two Psychostimulants doses)
Executive Functions consist of selective attention, working memory, response inhibition, reasoning, and set switching. Each of those component abilities will be assessed, scores converted to z scores, and a composite score assigned to each subject for each test session.
Measured: Day 1
Executive Functions (difference in performance on the two Psychostimulant doses)
Executive Functions consist of selective attention, working memory, response inhibition, reasoning, and set switching. Each of those component abilities will be assessed, scores converted to z scores, and a composite score assigned to each subject for each test session.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJun 2014
- 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 (8)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisordersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adele Diamond, University of British Columbia
- Investigators
- Adele Diamond, Ph.D., Principal investigator, Department of Psychiatry, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167048
- Sponsor's protocol ID
- H14-00224
- Status last verified
- May 2024
- First submitted
- 11 Jun 2014
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Barkley RA. Behavioral inhibition, sustained attention, and executive functions: constructing a unifying theory of ADHD. Psychol Bull. 1997 Jan;121(1):65-94. doi: 10.1037/0033-2909.121.1.65.
PubMed 9000892Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
PubMed 23020641Jacques, S., & Marcovitch, S. (2010). Development of executive function across the life span. In W. F. Overton (Ed.), Cognition, biology and methods across the lifespan: Volume 1 of the handbook of life-span development (pp. 431-466). Hoboken, NJ: Wiley.
Jucaite A, Fernell E, Halldin C, Forssberg H, Farde L. Reduced midbrain dopamine transporter binding in male adolescents with attention-deficit/hyperactivity disorder: association between striatal dopamine markers and motor hyperactivity. Biol Psychiatry. 2005 Feb 1;57(3):229-38. doi: 10.1016/j.biopsych.2004.11.009.
PubMed 15691523Waldman ID, Rowe DC, Abramowitz A, Kozel ST, Mohr JH, Sherman SL, Cleveland HH, Sanders ML, Gard JM, Stever C. Association and linkage of the dopamine transporter gene and attention-deficit hyperactivity disorder in children: heterogeneity owing to diagnostic subtype and severity. Am J Hum Genet. 1998 Dec;63(6):1767-76. doi: 10.1086/302132.
PubMed 9837830Berridge 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 16806100Schmeichel BE, Berridge CW. Neurocircuitry underlying the preferential sensitivity of prefrontal catecholamines to low-dose psychostimulants. Neuropsychopharmacology. 2013 May;38(6):1078-84. doi: 10.1038/npp.2013.6. Epub 2013 Feb 6.
PubMed 23303075Spencer 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 22209638
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
- Effects of Low-dose Versus Normal-dose Psychostimulants on Executive Functions in Individuals With Attention-Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02167048
- Acronym / sponsor ID
- H14-00224
- Keywords
- Attention Deficit Hyperactivity Disorders, Executive Function, Methylphenidate, Psychostimulants, Adolescent, Child, Working Memory, Prefrontal Cortex
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- 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.
This double-blind crossover study aims to compare cognitive performance (e.g., working memory, selective attention and cognitive flexibility) of children ages 6-18 years diagnosed with ADHD of the combined type (ADHD-C) or inattentive-type (ADHD-IA) and currently on > 20 mg/day of psychostimulants (psychostimulants) on: a) their current dose of psychostimulants, vs. b) a lower-dose of psychostimulants (half of their current dose).
The investigators hypothesize that the lower-dose psychostimulants will result in better cognitive performance than moderate-to-high doses of psychostimulants.
Detailed description
Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by attention deficits, hyperactivity, or impulsive actions that are not appropriate for the individuals' age (Barkley 1997). These behavioural issues arise relatively early in life, typically before the age of 12, and continue to persist into adulthood in many cases (Barkley 1997). In school-aged children, ADHD is associated with low academic achievement, poor school performance, anxiety and depression.
Symptoms are divided into inattention (e.g., easily distracted, difficulty focusing on \& completing a task), hyperactivity (e.g., constantly in motion, fidgets, squirms, talks non-stop), and impulsivity (e.g., difficult waiting one's turn, interrupting others). Three subtypes of ADHD have been identified: predominantly inattentive (ADHD-I), predominantly hyperactive-impulsive (ADHD-H), and the combined type (ADHD-C).
Psychostimulants in medium to high doses acts to inhibit re-uptake of dopamine by the dopamine transporter (DAT), resulting in increased dopamine concentrations in the synapse. DAT is abundant in the striatum, which is implicated in hyperactivity and impulsivity aspects of ADHD. However, DAT is sparse in prefrontal cortex (PFC), which plays a critical role in subserving executive functions. Executive functions (EFs; also called cognitive control or self-regulation) are a group of processes involved in concentration, focused attention, self-control, cognitive flexibility, problem-solving, and working memory (refs: Diamond, 2013; Jacques \& Marcovitch, 2010). Thus the number of high risk alleles of the gene that codes for the dopamine transporter (DAT1) are associated with hyperactivity (which depends on the striatum) but not inattention or EF deficits (which depend on PFC; refs: Jucaite et al., 2005; Waldman et al., 1998.
The action of low doses of psychostimulants has been shown to be different, however. At low doses psychostimulants has been demonstrated to act preferentially on PFC, increasing dopamine release (refs: Berridge et al., 2006; Schmeichel \& Berridge, 2013; Spencer et al, 2012). Thus, moderate to high doses of psychostimulants (doses most often prescribed for children and youths with ADHD) probably do not improve PFC function or EFs, or worse, may actually impair cognitive function, leaving a patient feeling more in a daze.
Optimal dosing for psychostimulants in children and youths with ADHD is usually determined by parents' reports of improved behaviour, almost never by performance on cognitive measures. We propose to look at cognitive performance on measures of attention, working memory, planning, etc. in children and youths with ADHD on their current dose of psychostimulants and on half that much (order counterbalanced across participants).
Purpose/Objectives: This double-blind crossover study aims to compare cognitive performance (e.g., working memory, selective attention and cognitive flexibility) of children ages 6-18 years diagnosed with ADHD of the combined type (ADHD-C) or inattentive-type (ADHD-IA) and currently on > 20 mg/day of psychostimulants on their current dose of psychostimulants and on a lower-dose of psychostimulants (half of their current dose), order counterbalanced across subjects.
To give us an estimate of order effects to help us correct for better performance in the 2nd session due simply to taking the same cognitive tests twice (note: the tests are Version A and B), we will also be recruiting healthy volunteers to serve as a control group. This control group will be strictly no intervention.
Hypotheses: The investigators hypothesize that lower-dose psychostimulants will result in better cognitive performance than moderate-to-high doses of psychostimulants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal-dose Psychostimulant, Low-dose | Experimental | Drug: PsychostimulantsNormal-dose: Dose participants are currently taking as part of their prescription (on more than or equals to 20 mg/day of Psychostimulants) Low-dose: Half the normal dose |
| Low-dose Psychostimulants, Normal-dose | Active comparator | Drug: PsychostimulantsNormal-dose: Dose participants are currently taking as part of their prescription (on more than or equals to 20 mg/day of Psychostimulants) Low-dose: Half the normal dose |
| No intervention, No intervention | No intervention | –This arm is completely no intervention, and is ONLY for healthy volunteers. We are testing healthy volunteers of the same age to give us an estimate of order effects to help us correct for better performance in the 2nd session due simply to taking the same tests twice (note: the tests are Version A and B). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Between the chronological ages of 6 and 18 years
- Average to above-average IQ (Parental report of an IQ above 90; we will take their word for it)
- Meet DSM-V criteria for ADHD (Combined type or Inattentive type)
- Currently treated with and responding to oral Psychostimulants >= 20 mg/day and not on a "drug holiday"
- Stable on current Psychostimulant dose for at least 2 weeks
Key exclusion criteria (10 listed)
- Patients with significant prior or current medical conditions that could impact neuropsychological performance such as traumatic brain injury, hypoxia, or unstable diabetes.
- Have any medical condition that could markedly increase sympathetic nervous system activity (e.g. catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (e.g. pseudoephedrine, oral steroids) that has sympathomimetic activity. Note: regular on-label use of inhalers for asthma (e.g., albuterol, steroidal) is permitted
- Taking any psychotropic medication other than on-label Psychostimulants specifically prescribed to treat ADHD
- Have a major, uncorrected sensory impairment (e.g. significant hearing impairment despite hearing aids)
- Lack sufficient English language skills to perform our tasks
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 |
|---|---|---|
| PsychostimulantsParticipants will be tested twice 2 weeks apart. All will continue on their normal Psychostimulant dose up until 3 days before the testing day. 3 days before their 1st testing session, half the participants will start on either their current-dose of Psychostimulant or half their current dose depending on the arm they were randomized to (we provide those pills). To control for different pharmacokinetics of the Psychostimulant medications, a given participant will be tested at roughly the peak time for his/her specific version of Psychostimulant and at the same time of day for his/her two testing sessions. | Drug | Low-dose Psychostimulants, Normal-dose, Normal-dose Psychostimulant, Low-dose |
Primary outcome
Executive Functions (difference in performance on the two Psychostimulants doses)
Time frame: Day 1
Executive Functions consist of selective attention, working memory, response inhibition, reasoning, and set switching. Each of those component abilities will be assessed, scores converted to z scores, and a composite score assigned to each subject for each test session.
Executive Functions (difference in performance on the two Psychostimulant doses)
Time frame: 2 weeks
Executive Functions consist of selective attention, working memory, response inhibition, reasoning, and set switching. Each of those component abilities will be assessed, scores converted to z scores, and a composite score assigned to each subject for each test session.
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 9000892Barkley RA. Behavioral inhibition, sustained attention, and executive functions: constructing a unifying theory of ADHD. Psychol Bull. 1997 Jan;121(1):65-94. doi: 10.1037/0033-2909.121.1.65.
- Background: PubMed 23020641Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- BackgroundJacques, S., & Marcovitch, S. (2010). Development of executive function across the life span. In W. F. Overton (Ed.), Cognition, biology and methods across the lifespan: Volume 1 of the handbook of life-span development (pp. 431-466). Hoboken, NJ: Wiley.
- Background: PubMed 15691523Jucaite A, Fernell E, Halldin C, Forssberg H, Farde L. Reduced midbrain dopamine transporter binding in male adolescents with attention-deficit/hyperactivity disorder: association between striatal dopamine markers and motor hyperactivity. Biol Psychiatry. 2005 Feb 1;57(3):229-38. doi: 10.1016/j.biopsych.2004.11.009.
- Background: PubMed 9837830Waldman ID, Rowe DC, Abramowitz A, Kozel ST, Mohr JH, Sherman SL, Cleveland HH, Sanders ML, Gard JM, Stever C. Association and linkage of the dopamine transporter gene and attention-deficit hyperactivity disorder in children: heterogeneity owing to diagnostic subtype and severity. Am J Hum Genet. 1998 Dec;63(6):1767-76. doi: 10.1086/302132.
- 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 23303075Schmeichel BE, Berridge CW. Neurocircuitry underlying the preferential sensitivity of prefrontal catecholamines to low-dose psychostimulants. Neuropsychopharmacology. 2013 May;38(6):1078-84. doi: 10.1038/npp.2013.6. Epub 2013 Feb 6.
- Background: PubMed 22209638Spencer 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.
- Individual participant dataSharing planned: Undecided
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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, Ph.D. principal investigator
Department of Psychiatry, 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 1/2 study testing Psychostimulants in people with Attention Deficit Hyperactivity Disorders, 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 8 inclusion and 10 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Functions (difference in performance on the two Psychostimulants doses) (time frame: Day 1). The study lists 2 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 NCT02167048, which also lists 8 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.