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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00633802
Enrollment
30
Registered
2008-03-12
Start date
2004-04-30
Completion date
Unknown
Last updated
2008-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderlone Personality Disorder

Keywords

Risperidone, Borderlone Personality Disorder

Brief summary

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.

Interventions

DRUGRisperidone

1 mg/d risperidone for 10 weeks or placebo

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
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.

Design outcomes

Primary

MeasureTime frame
Clinical Global Improvement Scale0, 1, 5, 10 week

Countries

Israel

Contacts

Primary ContactMiki Bloch, Ph.D.
mikib@tasmc.health.gov.il972-3-6974568

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026