Clinical trial
The Effect of Methylphenidate (Ritalin IR) Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
Name
SHEBA-12-8292-DG-CTIL
Description
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.
Trial arms
Trial start
2011-10-01
Estimated PCD
2014-04-01
Trial end
2014-04-01
Status
Completed
Treatment
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.
Arms:
couples of first-degree family members
Size
40
Primary endpoint
Clinical Global Impression-Improvement scale
CGI scale score at 4 weeks <=2
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-12-18
1 organization
1 product
4 indications
Organization
Sheba Medical CenterProduct
MethylphenidateIndication
ADHD Predominantly Hyperactivity TypeIndication
ADHD, not otherwise specified