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

This study is currently recruiting participants.
Verified March 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01554046
First received: February 23, 2012
Last updated: March 11, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Attention Deficit/Hyperactivity Disorder Combined Type
ADHD Predominantly Inattentive Type
ADHD Predominantly Hyperactivity Type
ADHD-not Other Specified
 Drug: Methylphenidate- Ritalin IR (Immediate Release)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Methylphenidate (Ritalin IR) Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Clinical Global Impression-Improvement scale [ Time Frame: CGI scale score at 4 weeks <=2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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%) ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2011
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554046

Contacts
Contact: Prof. Doron Gothelf, MD 972-52-6669360 gothelf@post.tau.ac.il

Locations
Israel
ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Prof. Doron Gothelf, MD     972-52-6669360     gothelf@post.tau.ac.il    
Sub-Investigator: Michal Gazer, M.sc student            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Prof. Doron Gothelf, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01554046     History of Changes
Other Study ID Numbers: SHEBA-12-8292-DG-CTIL
Study First Received: February 23, 2012
Last Updated: March 11, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Attention Deficit Hyperactivity Disorder (ADHD)
Methylphenidate- RITALIN IR (Immediate Release)

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013