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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Attention Deficit/Hyperactivity Disorder Combined Type, ADHD Predominantly Inattentive Type, ADHD Predominantly Hyperactivity Type, ADHD-not Other Specified

Intervention / Treatment
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* Drug: Methylphenidate- Ritalin IR (Immediate Release)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: couples of first-degree family members<br> | Drug: Methylphenidate- Ritalin IR (Immediate Release)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression-Improvement scale |  | CGI scale score at 4 weeks <=2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall ADHD-Rating Scale (ADHD-RS) score |  | change from baseline in ADHD-RS at 2 weeks (reducing >30%), change from baseline in ADHD-RS at 4 weeks (reducing >30%) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Hyperactivity Disorder (ADHD), Methylphenidate- RITALIN IR (Immediate Release)