ADHD-not Other Specified, ADHD Predominantly Hyperactivity Type, ADHD Predominantly Inattentive Type, Attention Deficit/Hyperactivity Disorder Combined Type
Conditions
Keywords
Attention Deficit Hyperactivity Disorder (ADHD), Methylphenidate- RITALIN IR (Immediate Release)
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.
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).
Interventions
DRUGMethylphenidate- 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.
Sponsors
Sheba Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impression-Improvement scale | CGI scale score at 4 weeks <=2 |
Secondary
| Measure | 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%) |
Countries
Israel
Outcome results
None listed