Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 3

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 description: 
      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
      study or, when appropriate, comparisons of baseline to endpoint will be made.
    

Intervention name(s): quetiapine extended-release; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo; Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo
Other intervention name(s): Seroquel XR; quetiapine extended-release
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Borderline Personality Disorder; BPD; Seroquel; Seroquel XR; quetiapine; quetiapine extended-release