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The Effect of Methylphenidate Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01554046
Recruitment Status : Recruiting
First Posted : March 14, 2012
Last Update Posted : March 14, 2012
Information provided by (Responsible Party):
Sheba Medical Center

Brief 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.

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

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: couples of first-degree family members Drug: 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.

Primary Outcome Measures :
  1. Clinical Global Impression-Improvement scale [ Time Frame: CGI scale score at 4 weeks <=2 ]

Secondary Outcome Measures :
  1. 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%) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • couples of first-degree family members, both diagnosed with ADHD (any type or ADHD-NOS) and need medical treatment.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01554046

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Contact: Prof. Doron Gothelf, MD 972-52-6669360

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ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Prof. Doron Gothelf, MD    972-52-6669360   
Sub-Investigator: Michal Gazer, student         
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Prof. Doron Gothelf, MD Sheba Medical Center

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Responsible Party: Sheba Medical Center Identifier: NCT01554046     History of Changes
Other Study ID Numbers: SHEBA-12-8292-DG-CTIL
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2012
Keywords provided by Sheba Medical Center:
Attention Deficit Hyperactivity Disorder (ADHD)
Methylphenidate- RITALIN IR (Immediate Release)
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents