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

ADHD Predominantly Inattentive Type Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554046
• Other study ID #: SHEBA-12-8292-DG-CTIL
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: December 2023
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD Predominantly Hyperactivity Type
• ADHD Predominantly Inattentive Type
• ADHD-not Other Specified
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder Combined Type
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
Israel	ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression-Improvement scale		CGI scale score at 4 weeks <=2
Secondary	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%)