Clinical trial NCT00633802: Low-Dose Risperidone Treatment for Subjects Suffering From Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderlone Personality Disorder
Keywords: Risperidone
Borderlone Personality Disorder
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-03-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Global Improvement Scale
timeFrame: 0, 1, 5, 10 week
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Psychiatric Service, Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: The Tel-Aviv Sourasky Medical Center
name: Miki Bloch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.