Clinical Trial: Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Seroquel XR for the Management of Borderline Personality Disorder (BPD)

Brief 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.


Detailed Summary:

The secondary objectives in this study are aimed at answering further questions regarding symptom assessments, dosing strategies, and safety. The specific secondary objectives are listed below:

  1. Response rate: In previous studies using the ZAN-BPD, response was defined as a 50% reduction of ZAN-BPD scores. Response rates will be compared between Seroquel XR and placebo.
  2. Other Symptom Measures: Over the last twenty years, other rating scales of a general nature have been used to assess BPD patients in clinical trials. To fully assess the patients as they progress through the study, the following scales will be administered: Symptom Checklist 90 - Revised (SCL-90 R), Montgomery Asberg Depression Rating Scale (MADRS), Barratt Impulsivity Scale (BIS), Schedule for Interviewing Borderlines (SIB), Overt Aggression Scale - Modified (OAS-M), Young Mania Rating Scale (YMRS), the Borderline Evaluation of Severity over Time (BEST), and the Global Assessment of Function (GAF).
  3. Side-Effects: To be able to report the safety of Seroquel XR for BPD, a combination of objective and subjective measures will be employed. Objectively, weight, height (and Body Mass Index (BMI)), prolactin, glucose, cholesterol and triglycerides will be assessed at baseline and endpoint. Objective ratings of movement side effects will be performed using Simpson Angus Scale (SAS) (Simpson and Angus 1970), Barnes Akathisia Scale (BAS) (Barnes 1989), and Abnormal Involuntary Movement Scale (AIMS) (Guy 1976), and at baseline and endpoint. Regarding possible side effects reported by patients, their reports of headache, somnolence, and other experiences will be tabulated.

Secondary objective data will be analyzed as continuous variable data over the time of the
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome:

  • Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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

    Original Primary Outcome: The Primary objective of this study is to determine if Seroquel XR is superior to placebo. The primary outcome measure will be a statistically significant difference between Seroquel XR. [ Time Frame: 8 weeks ]

    Current Secondary Outcome:

    Original Secondary Outcome: To be able to report the safety of Seroquel XR for BPD. Objectively, weight, height (and BMI), prolactin, glucose, cholesterol and triglycerides will be assessed at baseline and endpoint. [ Time Frame: 8 weeks ]

    Information By: University of Minnesota - Clinical and Translational Science Institute

    Dates:
    Date Received: April 10, 2009
    Date Started: June 2008
    Date Completion:
    Last Updated: January 26, 2017
    Last Verified: January 2017