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

NCT ID: NCT01554046

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-04-30

Brief Summary

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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

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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).

Conditions

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

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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couples of first-degree family members

Group Type EXPERIMENTAL

Methylphenidate- Ritalin IR (Immediate Release)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Doron Gothelf, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-12-8292-DG-CTIL

Identifier Type: -

Identifier Source: org_study_id