Low-Dose Risperidone Treatment for Subjects Suffering From Borderline Personality Disorder
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Borderlone Personality Disorder |
Drug: Risperidone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
- Clinical Global Improvement Scale [ Time Frame: 0, 1, 5, 10 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2004 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 2 |
Drug: Risperidone
1 mg/d risperidone for 10 weeks or placebo
|
| Experimental: 1 |
Drug: Risperidone
1 mg/d risperidone for 10 weeks or placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women with Borderline PD according to DSM-IV
- Signed informed consent.
- Age 18-45.
Exclusion Criteria:
- Psychotic disorders (past or present).
- Substance or alcohol related disorders (past or present).
- Current major depressive episode.
- Suicidal risk.
- History of head trauma, which caused loss of consciousness or peritraumatic amnesia or necessitated hospitalization.
- Any known psychiatric or general medical condition currently requiring specific medical attention.
- Current treatment with any antipsychotic, antidepressant drugs or mood stabilizers.
Contacts and Locations| Contact: Miki Bloch, Ph.D. | 972-3-6974568 | mikib@tasmc.health.gov.il |
| Israel | |
| Psychiatric Service, Tel-Aviv Sourasky Medical Center | Recruiting |
| Tel-Aviv, Israel | |
| Contact: Miki Bloch, Ph.D. 972-3-6974568 | |
| Principal Investigator: Miki Bloch, Ph.D. | |
| Principal Investigator: | Miki Bloch, Ph.D. | The Tel-Aviv Sourasky Medical Center |
More Information
No publications provided
| Responsible Party: | Miki Bloch, Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT00633802 History of Changes |
| Other Study ID Numbers: | 04-089 |
| Study First Received: | March 4, 2008 |
| Last Updated: | March 11, 2008 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Risperidone Borderlone Personality Disorder |
Additional relevant MeSH terms:
|
Personality Disorders Borderline Personality Disorder Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 19, 2013