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NCT00183339 · ClinicalTrials.gov registry record · Phase 2
Early Intervention With Fluoxetine in Autism
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00183339: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT00183339 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00183339, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study is a pilot study to evaluate the feasibility and safety of conducting a year long, double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance developmental processes in core areas impacted by autism.
Primary Outcome
In order for a larger trial with similar design to be feasible a number of factors needed to be examined. The first was whether families would enroll very young children with ASD into a year long blinded medication study. To determine this we examined the average number of months to randomize 1 participant per site. We calculated this (as total # months required for recruitment\* 2sites ) /\[ # participants randomized \] and compared it to the typical # of months required to recruit an older chi
Interventions
- DRUG Placebo
- DRUG Fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2005-07 |
| Est. Completion | 2008-02 |
| Phase | Phase 2 |
What the finished NCT00183339 record still lists
NCT00183339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00183339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00183339 about?
NCT00183339 is a clinical study titled "Early Intervention With Fluoxetine in Autism". This study is a pilot study to evaluate the feasibility and safety of conducting a year long, double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance developmental processes in core areas impacted by autism.
What is the current status of trial NCT00183339?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2005-07. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00183339?
The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT00183339?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00183339's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 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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