NCT00372359

Brief Summary

The purpose of this study is to find out whether prolonged treatment with methylphenidate has any adverse effect on cardiac functions and measurements.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2006

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

First QC Date

September 3, 2006

Last Update Submit

September 19, 2012

Conditions

Attention Deficit Disorder With HyperactivityAttention Deficit DisorderAttention Deficit Hyperactivity DisorderAttention Deficit Disorders With HyperactivityAttention Deficit Hyperactivity Disorders

Keywords

Attention Deficit DisorderHyperactivityMethylphenidate

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children aged 8-18 that are at least 5 years on methylphenidates

You may qualify if:

  • Children with ADHD aged 8-18 years who are taking methylphenydate (Ritalin©, Ritalin SR©, Ritalin LA©) for more than 5 years.

You may not qualify if:

  • Children with any known heart disease or anomaly. Children whose ADHD is part of a syndrome or are mentally retarded. Children that are on any other chronic medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Day Care Center, The Barzilai Medical Center

Ashkelon, 78306, Israel

RECRUITING

Related Publications (4)

  • Cohen AL, Jhung MA, Budnitz DS. Stimulant medications and attention deficit-hyperactivity disorder. N Engl J Med. 2006 May 25;354(21):2294-5. doi: 10.1056/NEJMc060860. No abstract available.

    PMID: 16723627BACKGROUND

  • Wooltorton E. Medications for attention deficit hyperactivity disorder: cardiovascular concerns. CMAJ. 2006 Jul 4;175(1):29. doi: 10.1503/cmaj.060718. Epub 2006 Jun 13. No abstract available.

    PMID: 16772535BACKGROUND

  • Nissen SE. ADHD drugs and cardiovascular risk. N Engl J Med. 2006 Apr 6;354(14):1445-8. doi: 10.1056/NEJMp068049. Epub 2006 Mar 20. No abstract available.

    PMID: 16549404BACKGROUND

  • Debate over warnings for ADHD stimulants. Child Health Alert. 2006 Apr;24:1. No abstract available.

    PMID: 16673500BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySpasm

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shraga Aviner, MD, PhD

    The Barzilai Medical Center, Ashkelon, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shraga Aviner, MD, PhD

CONTACT

972 3 674 5165aviners@barzi.health.govb.il

Olga Kissilgof, MD

CONTACT

972 8 674 5261

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
r&d unit

Study Record Dates

First Submitted

September 3, 2006

First Posted

September 6, 2006

Study Start

August 1, 2006

Study Completion

December 1, 2012

Last Updated

September 20, 2012

Record last verified: 2012-09

Locations

IL(1)