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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Borderlone Personality Disorder

Treatments: Drug: Risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT00633802

04-089

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Treatment:

Drug: Risperidone

1

Experimental group

Treatment:

Drug: Risperidone