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Seroquel 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 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.
Details
| Lead sponsor | University of Minnesota |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 95 |
| Start date | 2008-06 |
| Completion | 2013-03 |
Conditions
- Borderline Personality Disorder
Interventions
- quetiapine extended-release
- Placebo
Primary outcomes
- Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) — baseline, weekly until week 8
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. - Montgomery-Åsberg Depression Rating Scale (MADRS) — baseline to 8 weeks
Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression. - Borderline Evaluation of Severity Over Time (BEST) — Baseline to 8 weeks
Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst). - Overt Aggression Scale - Modified (OAS-M) — Change from Baseline Overt Aggression Scale - Modified to 8 weeks
Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms. - Global Assessment of Functioning Scale (GAF) — Change in Global Assessment of Functioning from Baseline to 8 weeks
Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional - Barratt Impulsiveness Scale (BIS) — Change in Impulsiveness from Baseline to 8 weeks
30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.
Countries
United States