Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD)
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Intervention: quetiapine extended-release; Placebo
Intervention description: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo; Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Borderline Personality Disorder; BPD; Seroquel; Seroquel XR; quetiapine; quetiapine extended-release

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consent

          -  A diagnosis of borderline personality disorder (301.83)

          -  All subjects will have a ZAN-BPD greater or equal to 9 at randomization.

          -  Males and females aged 18-45 years

          -  Female patients of childbearing potential must be using a reliable method of
             contraception and have a negative urine human chorionic gonadotropin (HCG) test at
             enrollment

          -  Able to understand and comply with the requirements of the study

        Exclusion Criteria:

          -  Pregnancy or lactation

          -  Any DSM-IV Axis I disorder not defined in the inclusion criteria. The patients with
             BPD may not have bipolar I disorder, schizophrenia, schizoaffective disorder,
             delirium, or dementia. Neither may they have current DSM-IV substance dependence.

          -  Patients who, in the opinion of the investigator, pose an imminent risk of suicide or
             a danger to self or others

          -  Known intolerance or lack of response to quetiapine fumarate, as judged by the
             investigator

          -  Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding
             enrollment including but not limited to: ketoconazole, itraconazole, fluconazole,
             erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir,
             fluvoxamine, and saquinavir

          -  Use of any of the following cytochrome P450 inducers in the 14 days preceding
             enrollment including but not limited to: phenytoin, carbamazepine, barbiturates,
             rifampin, St. John's Wort, and glucocorticoids

          -  Administration of a depot antipsychotic injection within one dosing interval (for the
             depot) before randomization

          -  Substance or alcohol dependence at enrollment (except dependence in full remission,
             and except for caffeine or nicotine dependence), as defined by DSM-IV criteria

          -  Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV
             criteria within 4 weeks prior to enrollment

          -  Medical conditions that would affect absorption, distribution, metabolism, or
             excretion of study treatment

          -  Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris,
             hypertension, congestive heart failure) as judged by the investigator

          -  Involvement in the planning and conduct of the study

          -  Previous enrollment or randomization of treatment in the present study.

          -  Participation in another drug trial within 4 weeks prior enrollment into this study or
             longer in accordance with local requirements

          -  Unstable Diabetes Mellitus

          -  An absolute neutrophil count (ANC) of 1.5 x 109 per liter

          -  Past history of lack of response to an atypical antipsychotic medication or
             substantial previous side effects will be cause for exclusion.

          -  Any medical illness that would interfere with conduct of the study will be cause for
             exclusion.

          -  Pregnant or lactating women and women of childbearing potential not using medically
             accepted means of contraception.