Attention Deficit Hyperactivity DisorderPhase 1NCT01040702
The Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults
A Phase 1 study testing methylphenidate and sweetener pill in people with Attention Deficit Hyperactivity Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
The aim of the study is to assess the effect of Methylphenidate on cognitive performance and decision-making ability of ADHD adults, and to compare this effect to the effect on healthy control adults. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- methylphenidate and sweetener pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 1
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults in the age of 21-50
Who cannot join
- pregnant or nursing women.
- people who suffer from a psychiatric disorder other than ADHD which could account for their inattention symptoms better than ADHD.
- people who lack judgment or are unable to communicate with the experimenters.
- people who are incapable of performing the computerized tasks due to sensory or motor disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Methylphenidate on Decision-making Ability of ADHD Adults
The aim of the study is to assess the effect of Methylphenidate on cognitive performance and decision-making ability of ADHD adults, and to compare this effect to the effect on healthy control adults.
Read the detailed description
Two matched groups of adults - with and without ADHD diagnosis - will perform a battery of computerized tasks assessing sustained attention,working-memory,non-verbal IQ,and decision-making ability. In each group,half of the participants will perform the tasks after receiving a capsule containing methylphenidate (MPH), and the other half will perform the tasks after receiving placebo. Task performance measures will then be compared in order to assess the effect of MPH on these domains.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- methylphenidate, sweetener pill
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidateDrug
Also called Ritalin
a single doses of 10-20 mg in each one of two visits
sweetener pillDietary supplement
Also called sukrazit
a capsule containing a sweetener pill
| Study group | Role | What they receive |
|---|---|---|
| ADHD -MPH | Experimental | adults with ADHD diagnosis who receive a single dose of Methylphenidate Receives: Drug: methylphenidate |
| ADHD-placebo | Placebo comparator | adults with ADHD diagnosis who received placebo Receives: Dietary Supplement: sweetener pill |
| non-ADHD-MPH | Experimental | healthy adults who received a single dose of Methylphenidate Receives: Drug: methylphenidate |
| non-ADHD-placebo | Placebo comparator | healthy adults who received placebo Receives: Dietary Supplement: sweetener pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
score in decision-making task 1
Measured: by the end of the task
Secondary outcomes (1)
working memory task score
Measured: by the end of the task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2009 (estimated)
- Study startJan 2008
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Investigators
- Ziv Carmel, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040702
- Sponsor's protocol ID
- SH-40107
- Status last verified
- Dec 2009
- First submitted
- 29 Dec 2009
- Last updated
- 30 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Methylphenidate on Decision-making Ability of ADHD Adults
- ClinicalTrials.gov ID
- NCT01040702
- Acronym / sponsor ID
- SH-40107
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Dec 2009 (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 aim of the study is to assess the effect of Methylphenidate on cognitive performance and decision-making ability of ADHD adults, and to compare this effect to the effect on healthy control adults.
Detailed description
Two matched groups of adults - with and without ADHD diagnosis - will perform a battery of computerized tasks assessing sustained attention,working-memory,non-verbal IQ,and decision-making ability. In each group,half of the participants will perform the tasks after receiving a capsule containing methylphenidate (MPH), and the other half will perform the tasks after receiving placebo. Task performance measures will then be compared in order to assess the effect of MPH on these domains.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADHD -MPH | Experimental | Drug: methylphenidateadults with ADHD diagnosis who receive a single dose of Methylphenidate |
| ADHD-placebo | Placebo comparator | Dietary Supplement: sweetener pilladults with ADHD diagnosis who received placebo |
| non-ADHD-MPH | Experimental | Drug: methylphenidatehealthy adults who received a single dose of Methylphenidate |
| non-ADHD-placebo | Placebo comparator | Dietary Supplement: sweetener pillhealthy adults who received placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adults in the age of 21-50
Key exclusion criteria (4 listed)
- pregnant or nursing women.
- people who suffer from a psychiatric disorder other than ADHD which could account for their inattention symptoms better than ADHD.
- people who lack judgment or are unable to communicate with the experimenters.
- people who are incapable of performing the computerized tasks due to sensory or motor disabilities.
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 |
|---|---|---|
| methylphenidateAlso: Ritalina single doses of 10-20 mg in each one of two visits | Drug | ADHD -MPH, non-ADHD-MPH |
| sweetener pillAlso: sukrazita capsule containing a sweetener pill | Dietary supplement | ADHD-placebo, non-ADHD-placebo |
Primary outcome
score in decision-making task 1
Time frame: by the end of the task
1 secondary outcome
working memory task score
Time frame: by the end of the task
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2009.
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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.
Ziv Carmel, MD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing methylphenidate and sweetener pill in people with Attention Deficit Hyperactivity Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
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 4 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: finished, as of the sponsor's last update on 30 Dec 2009. 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
score in decision-making task 1 (time frame: by the end of the task). 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 30 Dec 2009.