Attention Deficit/Hyperactivity Disorder Combined Type | The Effect of Methylphenidate Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
Attention Deficit/Hyperactivity Disorder Combined Type research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Attention Deficit/Hyperactivity Disorder Combined Type
ADHD Predominantly Inattentive Type
ADHD Predominantly Hyperactivity Type
ADHD-not Other Specified
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
couples of first-degree family members
Start Date: October 2011
Completed Date: December 2022
Primary Outcome: Clinical Global Impression-Improvement scale
Secondary Outcome: overall ADHD-Rating Scale (ADHD-RS) score
Study sponsors, principal investigator, and references
Principal Investigator: Prof. Doron Gothelf, MD
Lead Sponsor: Sheba Medical Center