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NCT00918567 · ClinicalTrials.gov registry record · Phase 4
Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD
A Phase 4 study, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT00918567 is a Phase 4 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 56 participants.
The verdict
NCT00918567, a Phase 4 study, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study Summary
Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there is only one published study specifically designed to evaluate its efficacy in school settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3 mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However, children are typically referred for treatment because of "real life" problems in functioning, not symptoms (Pelham, Fabiano, \& Massetti, 2005). While ATX has been found to produce functional improvements at home, the Weiss study found limited results in this area at school. Furthermore, almost no research has examined the effects of combining ATX and behavior therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of hyperactivity/impulsivity and increased the number of subjects reaching optimal response (Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve functional performance in the classroom. The effects of combined therapy may be even larger for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants. Objective: The primary objective was to evaluate the effects of ATX alone and in combination with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed using traditional symptoms measures as well as functional measures of academic and behavioral improvements in the classroom.
Interventions
- DRUG atomoxetine
- BEHAVIORAL Behavior Modification Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00918567
The ClinicalTrials.gov registry entry for NCT00918567 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which atomoxetine is the first listed.
NCT00918567 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00918567 about?
NCT00918567 is a clinical study titled "Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD". Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there is only one published study specifically designed to evaluate its efficacy in school settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3 mg/kg, significantly reduced teach...
What is the current status of trial NCT00918567?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2007-01. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00918567?
The interventions under investigation include: atomoxetine (DRUG), Behavior Modification Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT00918567?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
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