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NCT00880919 · ClinicalTrials.gov registry record · Phase 3
Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)
A Phase 3 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 3
- Development phase
- 95
- Enrollment target
NCT00880919: Completed Phase 3 study, sponsored by University of Minnesota.
NCT00880919 is a Phase 3 study that has completed, run by University of Minnesota. The registered enrollment target is 95 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00880919, a Phase 3 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 95 participants
- Enrollment target
Study Summary
The Primary objective of this study is to evaluate Seroquel XR in the treatment of borderline personality disorder (BPD). As in many initial randomized control trials, the study will be of relatively short duration - 8 weeks - to assess effectiveness and safety while maximizing retention. The specific aim is to determine if Seroquel XR is superior to placebo. The primary outcome measure will be a statistically significant difference between Seroquel XR compared to placebo on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD), an objective rating scale that addresses the severity of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) symptoms of the illness. As there is the recent development of an extended release form of Seroquel (Seroquel XR) (Schulz et al. 2007), the new compound may offer several advantages in this study. Therefore, the hypothesis of this study is that both doses of Seroquel XR (see below) will be superior to placebo in an 8-week randomized trial as assessed by the ZAN-BPD. To achieve the Primary Objective of this study, two doses of Seroquel XR will be tested - 150 mg/d and 300 mg/d. Thus, the study will be able to assess the effect of Seroquel XR compared to placebo and to explore a dose effect.
Primary Outcome
This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.
Interventions
- DRUG Placebo
- DRUG quetiapine extended-release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2008-06 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT00880919 record still lists
NCT00880919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00880919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00880919 about?
NCT00880919 is a clinical study titled "Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)". The Primary objective of this study is to evaluate Seroquel XR in the treatment of borderline personality disorder (BPD). As in many initial randomized control trials, the study will be of relatively short duration - 8 weeks - to assess effectiveness and safety while maximizing retention. The specif...
What is the current status of trial NCT00880919?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2008-06. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00880919?
The interventions under investigation include: Placebo (DRUG), quetiapine extended-release (DRUG).
Who is sponsoring clinical trial NCT00880919?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00880919's enrollment target sits among peer trials
95 1719th of 2000 higher than 282 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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