HealthyFDECNCT01993147
Functional Differences in Effortful Control
A study testing Dual task paradigm pilot in people with Healthy, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study was to learn more about the brain circuits involved with effortful control in healthy adult participants. It was planned that the study would enroll 80 participants to a dual task paradigm pilot while undergoing a fMRI scan to assess brain mechanisms that cause the "depletion effect". Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dual task paradigm pilot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2014to 8 Jun 2015
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handedness
Who cannot join
- Any clinically significant personal or family history of cardiac problems
- Any current Axis I psychiatric disorder (diagnosis as verified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV)
- A previous adequate trial with methylphenidate (Ritalin)
- Currently taking any psychoactive medications
- Any clinically significant medical condition
- Any clinically significant neurological problem (seizures, tics, serious head injury)
Show all 11Show fewer
- Contraindications to MRI (metal objects in body or claustrophobia)
- Currently pregnant or lactating
- Alcohol or substance abuse (current or in the past 2 years)
- Left-handedness or ambidextrous
- Liver or kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Rachel Upjohn Building, East Medical Campus
Ann Arbor, Michigan, 48109-2700
About this study
The purpose of this study was to learn more about the brain circuits involved with effortful control in healthy adult participants. It was planned that the study would enroll 80 participants to a dual task paradigm pilot while undergoing a fMRI scan to assess brain mechanisms that cause the "depletion effect". This effect refers to the observation that people perform more poorly on effortful control tasks after they have already performed task requiring effortful control. Then subsequent study participants would be given either methylphenidate (also known as 'Ritalin') which is FDA approved and the most widely-used medication for Attention Deficit Hyperactivity Disorder (ADHD) or a placebo, which is a sugar pill. Each participant would also perform some computer tasks that have been shown in previous studies to require effortful control while undergoing an fMRI (functional Magnetic Resonance Imaging) which takes a special kind of picture of the brain. The study's goal was to learn more about the brain mechanisms by which methylphenidate improves effortful control. After enrolling the first 50 participants, the study assessed whether a depletion effect was observed in the dual task paradigm. It was found that there was not: there was no statistically significant difference in effortful control performance comparing subjects who did and did not perform a prior effortful control task. Because the behavioral manipulation failed, it was determined that the drug manipulation portion of the study was no longer justified. Thus, after enrolling 50 participants to the pilot part of the study, the decision was made to terminate the study without beginning the trial of methylphenidate.
- Conditions
- Healthy
- Being tested
- Dual task paradigm pilot
- Keywords
- Methylphenidate, Placebo, functional Magnetic Resonance Imaging (fMRI), Attention Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual task paradigm pilotBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Dual Task Paradigm | Other | This arm does not involve any drug intervention, it is an experimental type consisting of 80 subjects to study the dual task paradigm implemented during the fMRI scanning session. 80 subjects will perform the fMRI scan but will not undergo any drug intervention. Receives: Behavioral: Dual task paradigm pilot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction Time on the Multi-Source Interference Task
Measured: 3 hours
Secondary outcomes (2)
Accuracy on the Multi-Source Interference Task
Accuracy is the calculated percentage of correct responses over total trials
Measured: 3 hours
Reaction time variability on the Multi-Source Interference Task
Reaction Time Variability is the standard deviation of the trial to trial reaction time distribution (the standard deviation is a unitless quantity) on the Multi-Source Interference Task.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start12 Sep 2014
- Primary completion8 Jun 2015
- Study completion8 Jun 2015
Why it stopped: Behavioral manipulation failed so the trial did not occur
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chandra Sekhar Sripada, University of Michigan
- Investigators
- Chandra Sekhar Sripada, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993147
- Sponsor's protocol ID
- IRB-MED-HUM00074465
- Acronym
- FDEC
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2013
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Differences in Effortful Control
- ClinicalTrials.gov ID
- NCT01993147
- Acronym / sponsor ID
- FDEC / IRB-MED-HUM00074465
- Conditions
- Healthy
- Keywords
- Methylphenidate, Placebo, functional Magnetic Resonance Imaging (fMRI), Attention Control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Behavioral manipulation failed so the trial did not occur
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 12 Sep 2014 (actual)
- Primary completion
- 8 Jun 2015 (actual)
- Study completion
- 8 Jun 2015 (actual)
- First posted
- 25 Nov 2013 (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.
The purpose of this study was to learn more about the brain circuits involved with effortful control in healthy adult participants. It was planned that the study would enroll 80 participants to a dual task paradigm pilot while undergoing a fMRI scan to assess brain mechanisms that cause the "depletion effect". This effect refers to the observation that people perform more poorly on effortful control tasks after they have already performed task requiring effortful control. Then subsequent study participants would be given either methylphenidate (also known as 'Ritalin') which is FDA approved and the most widely-used medication for Attention Deficit Hyperactivity Disorder (ADHD) or a placebo, which is a sugar pill. Each participant would also perform some computer tasks that have been shown in previous studies to require effortful control while undergoing an fMRI (functional Magnetic Resonance Imaging) which takes a special kind of picture of the brain. The study's goal was to learn more about the brain mechanisms by which methylphenidate improves effortful control. After enrolling the first 50 participants, the study assessed whether a depletion effect was observed in the dual task paradigm. It was found that there was not: there was no statistically significant difference in effortful control performance comparing subjects who did and did not perform a prior effortful control task. Because the behavioral manipulation failed, it was determined that the drug manipulation portion of the study was no longer justified. Thus, after enrolling 50 participants to the pilot part of the study, the decision was made to terminate the study without beginning the trial of methylphenidate.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual Task Paradigm | Other | Behavioral: Dual task paradigm pilotThis arm does not involve any drug intervention, it is an experimental type consisting of 80 subjects to study the dual task paradigm implemented during the fMRI scanning session. 80 subjects will perform the fMRI scan but will not undergo any drug intervention. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Right-handedness
Key exclusion criteria (11 listed)
- Any clinically significant personal or family history of cardiac problems
- Any current Axis I psychiatric disorder (diagnosis as verified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV)
- A previous adequate trial with methylphenidate (Ritalin)
- Currently taking any psychoactive medications
- Any clinically significant medical condition
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 |
|---|---|---|
| Dual task paradigm pilot | Behavioural | Dual Task Paradigm |
Primary outcome
Reaction Time on the Multi-Source Interference Task
Time frame: 3 hours
2 secondary outcomes
Accuracy on the Multi-Source Interference Task
Time frame: 3 hours
Reaction time variability on the Multi-Source Interference Task
Time frame: 3 hours
Results and safety
The study was stopped early (reason given: Behavioral manipulation failed so the trial did not occur). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
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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.
Chandra Sekhar Sripada, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual task paradigm pilot in people with Healthy, run by University of Michigan at 1 site in United States.
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 1 inclusion and 11 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: stopped early, as of the sponsor's last update on 2 Dec 2019. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Behavioral manipulation failed so the trial did not occur). 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?
Reaction Time on the Multi-Source Interference Task (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2019.