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NCT01109849 · ClinicalTrials.gov registry record · Phase 3
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
A Phase 3 study, sponsored by Florida International University.
- Completed
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
NCT01109849 is a Phase 3 study that has completed, run by Florida International University. The registered enrollment target is 230 participants.
The verdict
NCT01109849, a Phase 3 study, has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
Study Summary
Previous NIH funded Attention Deficit Hyperactivity Disorder (ADHD) trials in children found that daily stimulant therapy produced sustained growth deficits. However, no federally funded studies have examined the growth suppression associated with modern once a day stimulant medications. Therefore, this study will precisely estimate the risks of stimulant induced growth suppression (SIGS), examine the underlying mechanisms and develop treatments for it. While drug holidays and caloric supplementation are two common treatments for SIGS, there has been little systematic investigation of either. It is unknown if they are effective or feasible. Therefore, using a randomized adaptive design, we will evaluate the efficacy and feasibility of these two practices vs. routine monitoring of growth in 180 prepubertal children with ADHD. An additional 50 subjects will be treated solely with behavioral therapies to evaluate for growth abnormalities associated with ADHD. The study will assess will the risk of SIGS with ER stimulants and the underlying mechanisms while providing evidenced-based treatments for its management.
Interventions
- BEHAVIORAL behavior therapy
- DRUG Extended release (ER) methylphenidate product
- OTHER monitoring
- OTHER drug holiday
- DIETARY_SUPPLEMENT caloric supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2010-11 |
| Est. Completion | 2016-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01109849
The ClinicalTrials.gov registry entry for NCT01109849 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida International University, which has 89 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which behavior therapy is the first listed.
NCT01109849 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01109849 about?
NCT01109849 is a clinical study titled "Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth". Previous NIH funded Attention Deficit Hyperactivity Disorder (ADHD) trials in children found that daily stimulant therapy produced sustained growth deficits. However, no federally funded studies have examined the growth suppression associated with modern once a day stimulant medications. Therefore, ...
What is the current status of trial NCT01109849?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2010-11. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01109849?
The interventions under investigation include: behavior therapy (BEHAVIORAL), Extended release (ER) methylphenidate product (DRUG), monitoring (OTHER), drug holiday (OTHER), caloric supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01109849?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
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