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NCT00811473 · ClinicalTrials.gov registry record · Phase 3
Pediatric Bipolar Depression
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 193
- Enrollment target
NCT00811473: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00811473 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 193 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00811473, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 193 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).
Primary Outcome
Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).
Interventions
- DRUG Placebo
- DRUG Quetiapine XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00811473 record still lists
NCT00811473 is an interventional study that assigns participants to a tested intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00811473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00811473 about?
NCT00811473 is a clinical study titled "Pediatric Bipolar Depression". The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active ta...
What is the current status of trial NCT00811473?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 193 participants. The study started on 2009-01. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00811473?
The interventions under investigation include: Placebo (DRUG), Quetiapine XR (DRUG).
Who is sponsoring clinical trial NCT00811473?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00811473's enrollment target sits among peer trials
193 1397th of 2000 higher than 603 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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