NCT00183391

Brief Summary

This study will determine the effectiveness of stimulant and nonstimulant medication in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in children and adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7 years until next milestone

Results Posted

Study results publicly available

June 6, 2018

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

5.9 years

First QC Date

September 13, 2005

Results QC Date

April 17, 2017

Last Update Submit

May 4, 2018

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHDChildAdolescentSchool

Outcome Measures

Primary Outcomes (1)

  • ADHD-RS Total Score

    ADHD-RS Total Score Attention Deficit Hyperactivity Disorder Rating Scale. Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. Higher score indicates higher probability of diagnosis.

    up to 14 weeks

Secondary Outcomes (25)

  • Treatment Preference Survey

    Measured at ends of treatments one and two

  • ADHD - H/I

    up to 14 weeks

  • ADHD-RS Inattention

    up to 14 weeks

  • Clinical Global Impressions (CGI)- Severity

    up to 14 weeks

  • Social Skills Rating Scale (SSRS)- Parent Version

    up to 14 weeks

  • +20 more secondary outcomes

Study Arms (2)

Atomoxetine

ACTIVE COMPARATOR

Participants will receive treatment for ADHD with the non-stimulant atomoxetine

Drug: AtomoxetineDrug: Methylphenidate

Methylphenidate

ACTIVE COMPARATOR

Participants will receive treatment for ADHD with the stimulant methylphenidate

Drug: AtomoxetineDrug: Methylphenidate

Interventions

AtomoxetineDRUG

Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.

AtomoxetineMethylphenidate
MethylphenidateDRUG

Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.

AtomoxetineMethylphenidate

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meets DSM-IV-TR criteria for ADHD
  • Scores at least 1.5 standard deviation higher than age and gender mean on ADHD-RS keyed to ADHD subtype
  • CGI Severity ADHD Rating greater than or equal to 4
  • Currently attends school with at least 3 months left in high school
  • Currently lives at home with parent(s) or legal guardian(s), now and for the past year before study entry, and is expected to remain there
  • Normal physical exam, laboratory tests, and electrocardiogram
  • Pulse and blood pressure within 95% of age and gender mean
  • Full Scale IQ is greater than or equal to 75 OR if the results of testing indicate that Full Scale IQ is not a good indicator of intellectual ability, a General Ability Index greater than or equal to 75
  • Weight is between 20 and 85 kilograms
  • Able to swallow pills
  • Parent or guardian willing to provide informed consent

You may not qualify if:

  • History of atomoxetine or methylphenidate intolerance
  • Any existing medical condition for which study medications are contraindicated
  • If the child is in psychotherapy, no changes in therapy expected during the study trial
  • Presence of any of the following: autism, mental retardation, schizophrenia, a psychotic disorder, bipolar disorder, severe depression, or conduct disorder
  • Presence of a comorbid disorder that should be the primary focus of treatment
  • Presence of a medical or neurological disorder precluding study medications or assessing ADHD
  • Allergic reactions to multiple medications
  • History of alcohol or drug abuse in the 3 months before study entry, or positive urine toxic screen that is not explained by a time limited medical circumstance
  • Involved in a medication treatment study in the 30 days before study entry
  • Female who is sexually active and is unwilling to use birth control
  • Evidence of child abuse or neglect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois, Chicago - Institute for Juvenile Research

Chicago, Illinois, 60612, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

  • Bedard AC, Stein MA, Halperin JM, Krone B, Rajwan E, Newcorn JH. Differential impact of methylphenidate and atomoxetine on sustained attention in youth with attention-deficit/hyperactivity disorder. J Child Psychol Psychiatry. 2015 Jan;56(1):40-8. doi: 10.1111/jcpp.12272. Epub 2014 Jun 19.

    PMID: 24942409RESULT

  • Schulz KP, Bedard AV, Fan J, Hildebrandt TB, Stein MA, Ivanov I, Halperin JM, Newcorn JH. Striatal Activation Predicts Differential Therapeutic Responses to Methylphenidate and Atomoxetine. J Am Acad Child Adolesc Psychiatry. 2017 Jul;56(7):602-609.e2. doi: 10.1016/j.jaac.2017.04.005. Epub 2017 May 10.

    PMID: 28647012DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine HydrochlorideMethylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Jeffrey H Newcorn
Organization
Icahn School of Medicine at Mount Sinai
jeffrey.newcorn@mssm.edu
212-659-8705

Study Officials

  • Jeffrey H. Newcorn, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Mark A. Stein, PhD

    University of Illinois, Chicago - Institute for Juvenile Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

July 1, 2005

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 6, 2018

Results First Posted

June 6, 2018

Record last verified: 2018-05

Locations

US(2)