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International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder

NCT00863499 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1344

Last updated 2018-07-11

No results posted yet for this study

Summary

The aim of the iSPOT-A study is to:

1. identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity Disorder, and
2. identify brain, genetic and cognitive markers that predict treatment response to short-acting methylphenidate in children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder.

Conditions

  • Attention Deficit/Hyperactivity Disorder

Interventions

DRUG

Short Acting Methylphenidate

Dosage: 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended.

DRUG

Long Acting Methylphenidate

Dosage: 9 to 20 mg once daily in the morning (with or without food) with gradual increments of 9 to 20 mg weekly. Daily dosage above 60 mg is not recommended.

Sponsors & Collaborators

  • BRC Operations Pty. Ltd.

    lead INDUSTRY

Principal Investigators

  • Barbara A. Cohen, PhD · Center for Healing the Human Spirit

  • Harbans Multani, MD · Shanti Clinical Trials

  • Kamran Fallahpour, PhD · Brain Resource Center NY

  • Martijn Arns, PhD · Brainclinics Diagnostics B.V.

  • Mona Ismail, MD · Brain Resource Center NJ

  • Roger deBeus, PhD · Skyland Behavioral Health Associates

  • Simon Clarke, MD · Brain Dynamics Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States
  • Australia
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00863499 on ClinicalTrials.gov