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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 is a Phase 3 study that has completed, run by University of Minnesota. The registered enrollment target is 95 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00880919
The ClinicalTrials.gov registry entry for NCT00880919 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00880919 reports 0 study locations.
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.
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