NCT00885560

Brief Summary

To enhance our capacity to correctly choose the appropriate medication for ADHD patients on the first try based on the presence of a particular variant of a gene that could be identified on a laboratory test. It is hypothesized that patients with Attention Deficit Hyperactivity Disorder (ADHD) who have failed to respond to methylphenidate medication, but do respond to amphetamines, have a higher than expected incidence the allelic variants of the SNAP 25 gene associated with ADHD, and mutations of the dopamine system genes DRD1, 2, 4, 5 and dopamine transporter and COMTand MAOA.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

4 years

First QC Date

April 20, 2009

Last Update Submit

September 14, 2012

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

ADHDSNAP 25amphetaminemethylphenidate

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ADHD patients from 6 years of age

You may qualify if:

  • Patients will be male or female outpatients who are at least 6 years of age (there is no upper age limit)
  • Patients must meet DSM-IV criteria for ADHD
  • Patients and parents/guardians must have a degree of understanding sufficient to be able to communicate suitably with the investigator and study coordinator
  • Patients must have tolerated the drug at therapeutic doses, but have shown a true lack of improvement in symptoms
  • Must have shown clinically significant superiority in improvement in ADHD symptoms on amphetamine relative to MPH.

You may not qualify if:

  • Must not have a true allergy to methylphenidate or amphetamines
  • Must not have a history of serious adverse reactions to methylphenidate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Provincial ADHD Program, BC Children's & Women's Health Centre

Vancouver, British Columbia, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for genetic analysis.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Margaret D. Weiss, MD, Ph.D

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Jim Kennedy, MD

    University of British Columbia

    STUDY DIRECTOR

  • Atilla Turgay, MD

    British Columbia Children's & Women's Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

July 1, 2006

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

September 18, 2012

Record last verified: 2012-09

Locations

CA(1)