Attention Deficit Hyperactivity DisorderEarly Phase 1NCT00446537
Procedural Learning in Participants With ADHD
A Early Phase 1 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Skill acquisition refers to the process of improvement of performance following practice experience. This process is the basis for generation of a long-lasting memory. Individuals with Attention Deficit Hyperactivity Disorder (ADHD) have been shown to be impaired on some performance aspects of previously learned… Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Early 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 12 to 50 years
- All sexes
- Child, Adult
Who may be able to join
- Full scale IQ score of 85 or above
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Neuropediatric Unit
Jerusalem, 91031
Esther Adi-Japha, PhD, +972-3-5318704, japhae@mail.biu.ac.il
Ruth Shalev, MD
About this study
Skill acquisition refers to the process of improvement of performance following practice experience. This process is the basis for generation of a long-lasting memory. Individuals with Attention Deficit Hyperactivity Disorder (ADHD) have been shown to be impaired on some performance aspects of previously learned skills, an impairment that is often ameliorated, at least temporarily, by psychostimulant medication (the standard therapy in ADHD). The proposed study aims to define the course of learning and of generation of long-term memory consolidation in individuals with ADHD, and to essay the effectiveness of psychostimulant medication on both the learning and retention of the skills.
Read the detailed description
Skill Acquisition and the Evolution of Long Term Procedural Memory in participants with ADHD: The Effect of Methylphenidate
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate
- Keywords
- Skill Acquisition and the Evolution of Long Term Procedural Memory in participants with ADHD: The Effect of Methylphenidate
- 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.
MethylphenidateProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Esther Adi-Japha, PhD, Principal investigator, Bar-Ilan University, IsraelRuth Shalev, MD, Study chair, Shaare Zedek Medial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446537
- Sponsor's protocol ID
- 240446
- Status last verified
- Jan 2007
- First submitted
- 11 Mar 2007
- Last updated
- 13 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Learning in Participants With ADHD
- ClinicalTrials.gov ID
- NCT00446537
- Acronym / sponsor ID
- 240446
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Skill Acquisition and the Evolution of Long Term Procedural Memory in participants with ADHD: The Effect of Methylphenidate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- First posted
- 13 Mar 2007 (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.
Skill acquisition refers to the process of improvement of performance following practice experience. This process is the basis for generation of a long-lasting memory. Individuals with Attention Deficit Hyperactivity Disorder (ADHD) have been shown to be impaired on some performance aspects of previously learned skills, an impairment that is often ameliorated, at least temporarily, by psychostimulant medication (the standard therapy in ADHD). The proposed study aims to define the course of learning and of generation of long-term memory consolidation in individuals with ADHD, and to essay the effectiveness of psychostimulant medication on both the learning and retention of the skills.
Detailed description
Skill Acquisition and the Evolution of Long Term Procedural Memory in participants with ADHD: The Effect of Methylphenidate
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Full scale IQ score of 85 or above
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Methylphenidate | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2007.
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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.
Esther Adi-Japha, PhD principal investigator
Bar-Ilan University, Israel
Ruth Shalev, MD study chair
Shaare Zedek Medial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Shaare Zedek Medical 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 0 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 13 Mar 2007. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Esther Adi-Japha, PhD (972-3-5318704, japhae@mail.biu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 13 Mar 2007.