Borderlone Personality Disorder Clinical Trial
| NCT number | NCT00633802 |
| Other study ID # | 04-089 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | March 4, 2008 |
| Last updated | March 11, 2008 |
| Start date | April 2004 |
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | April 2009 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Psychiatric Service, Tel-Aviv Sourasky Medical Center | Tel-Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| Tel-Aviv Sourasky Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical Global Improvement Scale | 0, 1, 5, 10 week | No |