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NCT00178503 · ClinicalTrials.gov registry record · Phase 2
Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
A Phase 2 study of Autism and Attention Deficit Disorder With Hyperactivity, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00178503: Completed Phase 2 study of Autism and Attention Deficit Disorder With Hyperactivity, sponsored by The University of Texas Health Science Center, Houston.
NCT00178503 is a Phase 2 study of Autism and Attention Deficit Disorder With Hyperactivity that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 24 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00178503, a Phase 2 study of Autism and Attention Deficit Disorder With Hyperactivity, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This study examined the cognitive and behavioral differences in children who have an autism spectrum disorder (ASD) with or without additional symptoms of ADHD. The study also examined the effectiveness of a range of doses of methylphenidate in improving cognitive and behavioral outcomes in children with both ASD and ADHD.
Primary Outcome
The ADHD Index of the Conners' Teacher Rating Scale-Revised (CTRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Methylphenidate-extended release
- DRUG Methylphenidate-immediate release
Study Locations (1)
Texas
- University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2005-09 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT00178503 record still lists
NCT00178503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 183-participant average among 104 other Autism trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Autism appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00178503 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00178503 about?
NCT00178503 is a clinical study titled "Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children". This study examined the cognitive and behavioral differences in children who have an autism spectrum disorder (ASD) with or without additional symptoms of ADHD. The study also examined the effectiveness of a range of doses of methylphenidate in improving cognitive and behavioral outcomes in children...
What is the current status of trial NCT00178503?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2005-09. Estimated completion is 2011-05.
What conditions does trial NCT00178503 study?
This clinical trial studies the following conditions: Autism, Attention Deficit Disorder With Hyperactivity.
What interventions are being tested in trial NCT00178503?
The interventions under investigation include: Placebo (OTHER), Methylphenidate-extended release (DRUG), Methylphenidate-immediate release (DRUG).
Who is sponsoring clinical trial NCT00178503?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00178503 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism
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 NCT00178503's enrollment target sits among peer trials
24 86th of 104 higher than 17 of 104 other Autism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism 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.
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