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NCT01474746 · ClinicalTrials.gov registry record · Phase 2
Trial of Sertraline to Treat Children With Fragile X Syndrome
A Phase 2 study, sponsored by Randi J. Hagerman, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT01474746: Completed Phase 2 study, sponsored by Randi J. Hagerman, MD.
NCT01474746 is a Phase 2 study that has completed, run by Randi J. Hagerman, MD. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01474746, a Phase 2 study, has completed, sponsored by Randi J. Hagerman, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2 years to 5 years 8 months old. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in language and a decrease in autistic symptoms.
Primary Outcome
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administ
Interventions
- DRUG Placebo
- DRUG Sertraline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT01474746 record still lists
NCT01474746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01474746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01474746 about?
NCT01474746 is a clinical study titled "Trial of Sertraline to Treat Children With Fragile X Syndrome". This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2 years to 5 years 8 months old. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in languag...
What is the current status of trial NCT01474746?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2012-01. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01474746?
The interventions under investigation include: Placebo (DRUG), Sertraline (DRUG).
Who is sponsoring clinical trial NCT01474746?
This trial is sponsored by Randi J. Hagerman, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01474746's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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