deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT00183391

Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children

Measuring and Predicting Response to Atomoxetine and Methylphenidate

Sponsor: Icahn School of Medicine at Mount Sinai

Updated 7 times since 2017 Last updated: May 4, 2018 Started: Jul 31, 2005 Primary completion: Jun 30, 2011 Completion: Jun 30, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Attention Deficit Disorder With Hyperactivity, this trial is completed. The trial is conducted by Icahn School of Medicine at Mount Sinai and has accumulated 7 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

ADHD is one of the most frequently occurring disorders of children and adolescents and is a significant public health problem. The most common treatment for the condition is stimulant medication. However, there are an increasing number of children who are experiencing negative side effects from stimulants, such as dizziness, loss of appetite, and headaches; these side effects have made the need for alternative treatments all the more important. This study will compare the stimulant methylphenidate to the nonstimulant atomoxetine to determine which is more effective in treating ADHD symptoms in children and adolescents. The two medications differ in the neurotransmitters they influence. Stimulants such as methylphenidate act upon the neurotransmitter dopamine, while atomoxetine works on norepinephrine. It has been proposed that the difference in neurotransmitter stimulation may result in differences in an ADHD patient's response to treatment. Participants will be randomly assigned to receive either methylphenidate or atomoxetine for between 4 to 6 weeks, depending on how soon they respond to the treatment. After the 4 to 6 week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study. Participants will have up to 14 weekly study visits. Over the...

ADHD is one of the most frequently occurring disorders of children and adolescents and is a significant public health problem. The most common treatment for the condition is stimulant medication. However, there are an increasing number of children who are experiencing negative side effects from stimulants, such as dizziness, loss of appetite, and headaches; these side effects have made the need for alternative treatments all the more important. This study will compare the stimulant methylphenidate to the nonstimulant atomoxetine to determine which is more effective in treating ADHD symptoms in children and adolescents. The two medications differ in the neurotransmitters they influence. Stimulants such as methylphenidate act upon the neurotransmitter dopamine, while atomoxetine works on norepinephrine. It has been proposed that the difference in neurotransmitter stimulation may result in differences in an ADHD patient's response to treatment.

Participants will be randomly assigned to receive either methylphenidate or atomoxetine for between 4 to 6 weeks, depending on how soon they respond to the treatment. After the 4 to 6 week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.

Participants will have up to 14 weekly study visits. Over the first two visits, participants will undergo psychological and intelligence tests, a medical history, an electrocardiogram, blood and urine collection, and a physical exam. The remaining visits will occur weekly. During these visits, participants will receive their assigned medication and, along with their parents, will complete questionnaires about their response to treatment and any side effects they may be experiencing. The teachers of all participants will be asked to complete a questionnaire about their student's behavior at 4 different times during the study. Participant, parent, and teacher questionnaires will be used to assess the ADHD symptoms of participants, as well as self-report clinical scales completed by the participants.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotUnknown Status~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotUnknown Status~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotUnknown Status~Jul 2018 – ~Jan 2021 · 30 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Jul 2018 — Jan 2021 [monthly]

    Completed PHASE4

    Status: Unknown StatusCompleted · Phase: PHASE3PHASE4

  5. Jun 2018 — Jul 2018 [monthly]

    Unknown Status PHASE3

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Unknown Status PHASE3

  2. Jan 2017 — Feb 2017 [monthly]

    Unknown Status PHASE3

    First recorded

Jul 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Icahn School of Medicine at Mount Sinai
  • National Institute of Mental Health (NIMH)
Data source: Icahn School of Medicine at Mount Sinai

For direct contact, visit the study record on ClinicalTrials.gov .