Attention Deficit/Hyperactivity Disorder Combined TypeNCT01554046
The Effect of Methylphenidate Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
A study testing Methylphenidate- Ritalin IR (Immediate Release) in people with Attention Deficit/Hyperactivity Disorder Combined Type and ADHD Predominantly Inattentive Type, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to investigate the familial response to Methylphenidate treatment (Ritalin IR) in two aspects: ADHD symptom's improvement and side-effects development. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder Combined Type, ADHD Predominantly Inattentive Type, ADHD Predominantly Hyperactivity Type
- What is being tested?
- Methylphenidate- Ritalin IR (Immediate Release)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Apr 2014
- 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- couples of first-degree family members, both diagnosed with ADHD (any type or ADHD-NOS) and need medical treatment.
Who cannot join
- subjects who receive other psychiatric medications: antipsychotic medications, antidepressants medications, anti-anxiety medications or mood stabilizers.
- people who suffer from psychotic disorder, bipolar disorder or other severe psychiatric disorders which are not stabilized.
- Alcohol/drugs addicted.
- people with chronic neurologic diseases.
- people with Autism or mental retardation.
- people with congenital heart defect.
- people with hypertension/tachycardia (>100 bpm).
- pregnancy or breast feed women.
Trial locations and contacts
1 site in 1 country.
Israel1 site
ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center
Ramat Gan
About this study
Official title: The Effect of Methylphenidate (Ritalin IR) Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
The purpose of this study is to investigate the familial response to Methylphenidate treatment (Ritalin IR) in two aspects: ADHD symptom's improvement and side-effects development.
Read the detailed description
Attention Deficit/Hyperactivity Disorder (ADHD) is very prevalent and tends to continue from childhood to adult life. It's heritability is 76%. It was found that there is a greater ADHD prevalence in first-degree families of ADHD subjects- 4-6 times more than the general population.
Pharmacological treatment is the first line treatment today in ADHD, in children and adults, and Methylphenidate (specially Ritalin IR) is the first medication given for the disorder.
The study includes couples of first-degree family members, both diagnosed with ADHD. Subjects will receive Ritalin IR for 4 weeks and undergo several psychiatric and cognitive questionnaires at each time of the follow-up meeting (a total of 3).
- Conditions
- Attention Deficit/Hyperactivity Disorder Combined Type, ADHD Predominantly Inattentive Type, ADHD Predominantly Hyperactivity Type, ADHD-not Other Specified
- Being tested
- Methylphenidate- Ritalin IR (Immediate Release)
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD), Methylphenidate- RITALIN IR (Immediate Release)
- 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.
Methylphenidate- Ritalin IR (Immediate Release)Drug
Duration of treatment- 4 weeks. Dosage- up to 3 times/day.
- Ages 6-12, up to 25Kg - 35mg maximum per day.
- Ages 6-12, above 25Kg - 50mg maximum per day.
- Ages 12-65, above 25Kg - 80mg maximum per day.
| Study group | Role | What they receive |
|---|---|---|
| couples of first-degree family members | Experimental | Not described Receives: Drug: Methylphenidate- Ritalin IR (Immediate Release) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression-Improvement scale
Measured: CGI scale score at 4 weeks <=2
Secondary outcomes (1)
overall ADHD-Rating Scale (ADHD-RS) score
Measured: change from baseline in ADHD-RS at 2 weeks (reducing >30%), change from baseline in ADHD-RS at 4 weeks (reducing >30%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit/Hyperactivity Disorder Combined TypeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Prof. Doron Gothelf, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554046
- Sponsor's protocol ID
- SHEBA-12-8292-DG-CTIL
- Status last verified
- Dec 2023
- First submitted
- 23 Feb 2012
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Methylphenidate (Ritalin IR) Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01554046
- Acronym / sponsor ID
- SHEBA-12-8292-DG-CTIL
- Conditions
- Attention Deficit/Hyperactivity Disorder Combined Type, ADHD Predominantly Inattentive Type, ADHD Predominantly Hyperactivity Type, ADHD-not Other Specified
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD), Methylphenidate- RITALIN IR (Immediate Release)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 14 Mar 2012 (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 is to investigate the familial response to Methylphenidate treatment (Ritalin IR) in two aspects: ADHD symptom's improvement and side-effects development.
Detailed description
Attention Deficit/Hyperactivity Disorder (ADHD) is very prevalent and tends to continue from childhood to adult life. It's heritability is 76%. It was found that there is a greater ADHD prevalence in first-degree families of ADHD subjects- 4-6 times more than the general population.
Pharmacological treatment is the first line treatment today in ADHD, in children and adults, and Methylphenidate (specially Ritalin IR) is the first medication given for the disorder.
The study includes couples of first-degree family members, both diagnosed with ADHD. Subjects will receive Ritalin IR for 4 weeks and undergo several psychiatric and cognitive questionnaires at each time of the follow-up meeting (a total of 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| couples of first-degree family members | Experimental | Drug: Methylphenidate- Ritalin IR (Immediate Release) |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- couples of first-degree family members, both diagnosed with ADHD (any type or ADHD-NOS) and need medical treatment.
Key exclusion criteria (8 listed)
- subjects who receive other psychiatric medications: antipsychotic medications, antidepressants medications, anti-anxiety medications or mood stabilizers.
- people who suffer from psychotic disorder, bipolar disorder or other severe psychiatric disorders which are not stabilized.
- Alcohol/drugs addicted.
- people with chronic neurologic diseases.
- people with Autism or mental retardation.
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- Ritalin IR (Immediate Release)Duration of treatment- 4 weeks. Dosage- up to 3 times/day. * Ages 6-12, up to 25Kg - 35mg maximum per day. * Ages 6-12, above 25Kg - 50mg maximum per day. * Ages 12-65, above 25Kg - 80mg maximum per day. | Drug | couples of first-degree family members |
Primary outcome
Clinical Global Impression-Improvement scale
Time frame: CGI scale score at 4 weeks <=2
1 secondary outcome
overall ADHD-Rating Scale (ADHD-RS) score
Time frame: change from baseline in ADHD-RS at 2 weeks (reducing >30%), change from baseline in ADHD-RS at 4 weeks (reducing >30%)
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 18 Dec 2023.
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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.
Prof. Doron Gothelf, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate- Ritalin IR (Immediate Release) in people with Attention Deficit/Hyperactivity Disorder Combined Type and ADHD Predominantly Inattentive Type, run by Sheba 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 8 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 18 Dec 2023. 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.
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?
Clinical Global Impression-Improvement scale (time frame: CGI scale score at 4 weeks <=2). 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 18 Dec 2023.