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

Sponsor

Sheba Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT01554046

Collaborator

(none)

400

Enrollment

Location

Arm

146

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit/Hyperactivity Disorder Combined Type ADHD Predominantly Inattentive Type ADHD Predominantly Hyperactivity Type ADHD-not Other Specified	Drug: Methylphenidate- Ritalin IR (Immediate Release)	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: couples of first-degree family members	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.

Arm

Intervention/Treatment

Experimental: couples of first-degree family members

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.

Outcome Measures

Primary Outcome Measures

Clinical Global Impression-Improvement scale [CGI scale score at 4 weeks <=2]

Secondary Outcome Measures

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%)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.