The Effect of Methylphenidate Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
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|ClinicalTrials.gov Identifier: NCT01554046|
Recruitment Status : Recruiting
First Posted : March 14, 2012
Last Update Posted : March 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit/Hyperactivity Disorder Combined Type ADHD Predominantly Inattentive Type ADHD Predominantly Hyperactivity Type ADHD-not Other Specified||Drug: Methylphenidate- Ritalin IR (Immediate Release)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Methylphenidate (Ritalin IR) Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||December 2022|
|Experimental: couples of first-degree family members||
Drug: Methylphenidate- Ritalin IR (Immediate Release)
Duration of treatment- 4 weeks. Dosage- up to 3 times/day.
- Clinical Global Impression-Improvement scale [ Time Frame: CGI scale score at 4 weeks <=2 ]
- 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%) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554046
|Contact: Prof. Doron Gothelf, MDfirstname.lastname@example.org|
|ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center||Recruiting|
|Contact: Prof. Doron Gothelf, MD 972-52-6669360 email@example.com|
|Sub-Investigator: Michal Gazer, M.sc student|
|Principal Investigator:||Prof. Doron Gothelf, MD||Sheba Medical Center|