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

Primary Purpose

Attention Deficit/Hyperactivity Disorder Combined Type, ADHD Predominantly Inattentive Type, ADHD Predominantly Hyperactivity Type

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Methylphenidate- Ritalin IR (Immediate Release)
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder Combined Type focused on measuring Attention Deficit Hyperactivity Disorder (ADHD), Methylphenidate- RITALIN IR (Immediate Release)

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

couples of first-degree family members

Arm Description

Outcomes

Primary Outcome Measures

Clinical Global Impression-Improvement scale

Secondary Outcome Measures

overall ADHD-Rating Scale (ADHD-RS) score

Full Information

First Posted
February 23, 2012
Last Updated
May 16, 2022
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01554046
Brief Title
The Effect of Methylphenidate Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
Official Title
The Effect of Methylphenidate (Ritalin IR) Treatment in Familial Attention Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
couples of first-degree family members
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methylphenidate- Ritalin IR (Immediate Release)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Global Impression-Improvement scale
Time Frame
CGI scale score at 4 weeks <=2
Secondary Outcome Measure Information:
Title
overall ADHD-Rating Scale (ADHD-RS) score
Time Frame
change from baseline in ADHD-RS at 2 weeks (reducing >30%), change from baseline in ADHD-RS at 4 weeks (reducing >30%)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Doron Gothelf, MD
Phone
972-52-6669360
Email
gothelf@post.tau.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Doron Gothelf, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center
City
Ramat-Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Doron Gothelf, MD
Phone
972-52-6669360
Email
gothelf@post.tau.ac.il
First Name & Middle Initial & Last Name & Degree
Michal Gazer, M.sc student

12. IPD Sharing Statement

Learn more about this trial

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

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