Low-Dose Risperidone Treatment for Subjects Suffering From Borderline Personality Disorder

Personality disorders are life-long maladaptive behavioral patterns. Borderline personality disorder (BPD) is the leading personality disorder encountered in clinical settings, often associated with tremendous distress. It is characterized by impulsivity, emotional lability, unstable interpersonal relationships, with particular sensitivity to abandonment. BPD patients are prone to self destructive behaviors and all too frequently attempt suicide.

When in emotional turmoil, persons with BPD may also develop brief, transient psychotic states.

Psychotherapy for BPD is a common treatment option, but it requires considerable time and specific personnel training, and is therefore not always feasible. Medical treatment is an efficacious alternative, however there is no concensus on drug selection. Some experts have suggested that medical treatment should be selected individually according to the subject's dominant clinical symptom. Several psychopharmacological groups have been proposed:

Antidepressants, mood stabilizers, and several novel antipsychotic drugs. The latter are particularly promising since they may produce symptomaic improvement with fewer adverse effects. Risperidone has been shown in a few preliminary studies to be promising in the treatment of various BPD symptoms, but no controlled study has tested it yet. We propose to test the efficacy of risperidone in the treatment of BPD in a double-blind crossover design using both clinical and phsysiological measure.The main hypothesis is that risperidone will be efficient in alleviating BPD core and secondary symptoms.

Intervention(s) in this Clinical Trial

• Drug: Risperidone
  • 1 mg/d risperidone for 10 weeks or placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 2
• Experimental: 1

Primary Measures

• Clinical Global Improvement Scale
  • Time Frame: 0, 1, 5, 10 week
    Safety Issue?: No

Inclusion Criteria:

• 1. Women with Borderline PD according to DSM-IV
• 2. Signed informed consent.
• 3. Age 18-45.

Exclusion Criteria:

• 1. Psychotic disorders (past or present).
• 2. Substance or alcohol related disorders (past or present).
• 3. Current major depressive episode.
• 4. Suicidal risk.
• 5. History of head trauma, which caused loss of consciousness or peritraumatic amnesia or necessitated hospitalization.
• 6. Any known psychiatric or general medical condition currently requiring specific medical attention.
• 7. Current treatment with any antipsychotic, antidepressant drugs or mood stabilizers.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Tel-Aviv Sourasky Medical Center Other

Overall Clinical Trial Officials and Contacts

Miki Bloch, Ph.D. Principal Investigator The Tel-Aviv Sourasky Medical Center  

Overall Contact: Miki Bloch, Ph.D. 972-3-6974568 mikib@tasmc.health.gov.il

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00633802

Study ID Number: 04-089

ClinicalTrials.gov Identifier: NCT00633802

Health Authority: Israel: Ethics Commission