Risperidone Treatment of Borderline Personality Disorder Assessed by a Borderline Personality Disorder–Specific Outcome Measure

To the Editors: Borderline personality disorder (BPD) has a prevalence of 1.4% and results in high rates of mortality (9%), morbidity, and comorbidity, and in disproportionately high uses of primary medical and psychiatric services. One of the most promising lines of pharmacotherapeutic research in BPD has evolved from the observed effects of low doses of neuroleptics. According to the American Psychiatric Association practice guideline, antipsychotic agents are recommended in patients with BPD who present with cognitive-perceptual symptoms, acute anger, hostility, assaultiveness, and self-injury. Placebocontrolled studies of these agents in BPD have consistently demonstrated significant symptom reduction. However, improvement in symptoms within and between the 4 behavioral dimensions of BPD (affective dysregulation, impulsivity, cognitive-perceptual impairment, and disturbed relationships) has varied among studies, even between those utilizing the same drug. This inconsistent pattern of efficacy of antipsychotic agents in BPD may be due, in part, to the treatment outcome measures used. No published study has utilized an instrument developed to evaluate treatment change in the specific symptoms and behavioral dimensions of BPD, possibly resulting in the observed inconsistency of findings and a bias in favor of type II errors. In general, condition-specific instruments seem to provide greater sensitivity to change. A self-report treatment outcome measure evaluating the symptoms and symptom domains of BPD may provide enhanced sensitivity and validity in evaluating treatment effects in this population and would complement the clinician-administered Zanarini Rating Scale for BPD (ZAN-BPD). Finally, there are conflicting results from the only 2 studies evaluating the efficacy of risperidone in BPD, a medication used off-label in patients with the disorder. Therefore, the primary objectives of this pilot study were to test the efficacy and tolerability of risperidone in subjects with BPD and to provide a preliminary evaluation of the utility of a new self-report treatment outcome measure for BPD, the Borderline Disorder Rating Scale (BDRS). Approval for this open-label trial was obtained from the University of Alabama at Birmingham (UAB) institutional review board, and written informed consent was obtained from all subjects. Female subjects were recruited from newspaper advertisements and from physicians practicing at UAB. Subjects met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for BPD (Structured Clinical Interview for DSM-IV Axis II Personality Disorders), scored 8 or higher on the Revised Diagnostic Interview for Borderlines, used an accepted means of contraception, and demonstrated an understanding of all tests and examinations used. Exclusion criteria were participation in a clinical drug trial within 1 month before study entry; currently pregnant or nursing; current diagnosis of any DSM-IVAxis I disorder (with the exception of dysthymia, posttraumatic stress disorder, generalized anxiety disorder, or substance abuse or dependence inactive for the prior 3 months); current schizotypal or antisocial personality disorder; active suicidal ideation with a plan; serious, unstable medical illnesses; use of any additional psychotropic medication during or within 4 weeks before the study, except for a maintenance dose of antidepressants; and treatment with any form of psychotherapy during the study. Comprehensive physical and psychiatric histories and examinations and laboratory studies were performed at entry into and upon completion of the study. One of the 2 primary treatment outcome measures used in the study was the BDRS, a 40-item scale developed by 4 of the authors (R.O.F., W.T.J., R.S.M., and A.S.) then at the UAB BPD Program. Four groups of 10 items each were developed to evaluate change in the 4 domains of BPD. A more complete description and a copy of the BDRS are available from the corresponding author. Further evaluation of its psychometric properties will be published elsewhere. Upon entry into the study, all subjects completed a battery of outcome measures that was readministered at the end of weeks 2, 4, 6, and 8. These included the BDRS and the second primary outcome measure, the Brief Symptom Inventory (BSI; 53 items); the State-Trait Anger Expression Inventory 2 (57 items); the Beck Depression Inventory II (26 items); the Barratt Impulsiveness Scale, 11th version (BIS-11; 30 items); the Quality of Life Enjoyment and Satisfaction Questionnaire (feelings, work, and social relations subscales); the Clinical Global Impression (CGI)—Severity and Improvement Clinician-Rated; the CGIImprovement Patient-Rated Scales; and the Social Desirability Scale. Safety and tolerability were assessed by clinicians at each visit using the treatment emergent signs and symptoms. The initial dose of risperidone for all subjects was 0.25 mg/d, given at bedtime to minimize any impairment due to somnolence. The dose was adjusted at each visit based on clinical perception of efficacy and tolerability, to a maximum dosage of 2 mg/d, a dose limit used to optimize tolerability as a result of experience in the UAB BPD Clinic. The dose was reduced at any time if, in the clinician’s judgment, adverse effects or poor tolerability indicated doing so. Letters to the Editors