The Effect of Methylphenidate 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.

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Key information

Conditions

Attention Deficit/Hyperactivity Disorder Combined Type ADHD Predominantly Hyperactivity Type ADHD Predominantly Inattentive Type ADHD-not Other Specified Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center

Ramat Gan, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Clinical Global Impression-Improvement scale

Time frame: CGI scale score at 4 weeks <=2

Secondary outcomes

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%)

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Mar 14, 2012
Registry last updated: Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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