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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: Completed Phase 3 study, sponsored by Florida International University.
NCT01109849 is a Phase 3 study that has completed, run by Florida International University. The registered enrollment target is 230 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint will be change in z-height at month 30 which is study endpoint. Measured as a zscore with more negative units reflecting smaller incremental height gain. Z units used to account for differences between groups in gender and age with both impact height at a fixed time.
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 |
What the finished NCT01109849 record still lists
NCT01109849 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which behavior therapy is the first listed.
NCT01109849 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01109849's enrollment target sits among peer trials
230 1304th of 2000 higher than 692 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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