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

NCT01554046 | Completed

• 1 other identifier: SHEBA-12-8292-DG-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit/Hyperactivity Disorder Combined Type; ADHD Predominantly Inattentive Type; ADHD Predominantly Hyperactivity Type; ADHD-not Other Specified

Keywords

Attention Deficit Hyperactivity Disorder (ADHD); Methylphenidate- RITALIN IR (Immediate Release)

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression-Improvement scale

  CGI scale score at 4 weeks <=2

Secondary Outcomes (1)

• 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%)

Study Arms (1)

couples of first-degree family members

EXPERIMENTAL

Drug: Methylphenidate- Ritalin IR (Immediate Release)

Interventions

Methylphenidate- Ritalin IR (Immediate Release) DRUG

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.

couples of first-degree family members

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• couples of first-degree family members, both diagnosed with ADHD (any type or ADHD-NOS) and need medical treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Prof. Doron Gothelf, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 14, 2012
• Study Start: October 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

IL (1)