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NCT01727414 · ClinicalTrials.gov registry record · Phase 4
Attention Deficit Disorder Medication Response Study
A Phase 4 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 171
- Enrollment target
NCT01727414 is a Phase 4 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 171 participants.
The verdict
NCT01727414, a Phase 4 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 171 participants
- Enrollment target
Study Summary
This study evaluates how children with Attention Deficit Disorder without Hyperactivity (ADD) respond to medication, and if their response is different from children who have problems with both hyperactivity and inattention. In order to do this, children ages 7-11 whose primary difficulty is with attention problems and who have never been on behavioral or psychiatric medications are being recruited. Once enrolled, children will try one week each of 3 different doses of methylphenidate, the most commonly prescribed Attention Deficit, Hyperactivity Disorder (ADHD) medication, as well as placebo. Children will be randomly assigned to one of six possible medication dose and placebo titration schedules, but the study doctor, family, and teacher will not know which dose (if any) children are receiving for a given week. Each week, behavioral and side effect ratings will be completed by both the child's parent and teacher, and the family will meet with the study doctor for a physical examination and to discuss how each week went. Some children will also have neuropsychological testing to determine how methylphenidate influences their working memory, sustained attention, and ability to inhibit (stop) inappropriate responses. All data will be analyzed to decide which medication dose the child responded to best and further recommendations for treatment will be given. Ultimately, this study aims to improve understanding of how children with ADHD-Primarily Inattentive Type respond to stimulant medications by * determining whether these children experience a diminished response to methylphenidate compared to children with both hyperactivity and inattention * determining whether certain genetic and environmental factors play a role in this response. Findings from this study will be used to help streamline the identification of the most effective doses of medication for children with ADHD-Primarily Inattentive Type.
Interventions
- DRUG OROS-Methylphenidate and placebo for inattentive type pts
- DRUG OROS-Methylphenidate and placebo for combined type pts
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2006-06 |
| Est. Completion | 2014-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01727414
The ClinicalTrials.gov registry entry for NCT01727414 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 171 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which OROS-Methylphenidate and placebo for inattentive type pts is the first listed.
NCT01727414 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01727414 about?
NCT01727414 is a clinical study titled "Attention Deficit Disorder Medication Response Study". This study evaluates how children with Attention Deficit Disorder without Hyperactivity (ADD) respond to medication, and if their response is different from children who have problems with both hyperactivity and inattention. In order to do this, children ages 7-11 whose primary difficulty is with at...
What is the current status of trial NCT01727414?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 171 participants. The study started on 2006-06. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01727414?
The interventions under investigation include: OROS-Methylphenidate and placebo for inattentive type pts (DRUG), OROS-Methylphenidate and placebo for combined type pts (DRUG).
Who is sponsoring clinical trial NCT01727414?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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