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NCT00844857 · ClinicalTrials.gov registry record · Phase 4
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 291
- Enrollment target
NCT00844857: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT00844857 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 291 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00844857, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 291 participants
- Enrollment target
Study Summary
The main goal of this study is to help answer the following research question(s) and not to treat the child's illness. * Can this study drug make children with bipolar depression feel better? * Does this study drug work better than a placebo (sugar pill)? * Does this study drug cause side effects in children who take it? * Is this drug safe to use in children? (The study drug is a mixture of olanzapine and fluoxetine)
Primary Outcome
CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) mean was adjusted for baseline, country, treatment, visit, and treatment times (\
Interventions
- DRUG Placebo
- DRUG Olanzapine Fluoxetine Combination (OFC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2009-04 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT00844857 record still lists
NCT00844857 is an interventional study that assigns participants to a tested intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00844857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00844857 about?
NCT00844857 is a clinical study titled "A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression". The main goal of this study is to help answer the following research question(s) and not to treat the child's illness. * Can this study drug make children with bipolar depression feel better? * Does this study drug work better than a placebo (sugar pill)? * Does this study drug cause side effects i...
What is the current status of trial NCT00844857?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 291 participants. The study started on 2009-04. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00844857?
The interventions under investigation include: Placebo (DRUG), Olanzapine Fluoxetine Combination (OFC) (DRUG).
Who is sponsoring clinical trial NCT00844857?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00844857's enrollment target sits among peer trials
291 297th of 2000 higher than 1,704 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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