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NCT02385799 · ClinicalTrials.gov registry record · Phase 2
A Trial of Sertraline in Young Children With Autism Spectrum Disorder
A Phase 2 study of Autism Spectrum Disorder, sponsored by Randi J. Hagerman, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT02385799: Completed Phase 2 study of Autism Spectrum Disorder, sponsored by Randi J. Hagerman, MD.
NCT02385799 is a Phase 2 study of Autism Spectrum Disorder that has completed, run by Randi J. Hagerman, MD. The registered enrollment target is 58 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02385799, a Phase 2 study of Autism Spectrum Disorder, has completed, sponsored by Randi J. Hagerman, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old inclusive with Autism Spectrum Disorder. 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 social deficits.
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
Conditions Studied
Interventions
- DRUG Sertraline
- DRUG Sertraline Liquid Placebo
Study Locations (1)
California
- UC Davis MIND Institute - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2015-04 |
| Est. Completion | 2018-07 |
| Phase | Phase 2 |
What the finished NCT02385799 record still lists
NCT02385799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sertraline is the first listed.
NCT02385799 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02385799 about?
NCT02385799 is a clinical study titled "A Trial of Sertraline in Young Children With Autism Spectrum Disorder". This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old inclusive with Autism Spectrum Disorder. 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 l...
What is the current status of trial NCT02385799?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2015-04. Estimated completion is 2018-07.
What conditions does trial NCT02385799 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
What interventions are being tested in trial NCT02385799?
The interventions under investigation include: Sertraline (DRUG), Sertraline Liquid Placebo (DRUG).
Who is sponsoring clinical trial NCT02385799?
This trial is sponsored by Randi J. Hagerman, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02385799 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02385799's enrollment target sits among peer trials
58 131st of 224 higher than 92 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder 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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