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Sponsored by: |
Tel-Aviv Sourasky Medical Center |
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Information provided by: | Tel-Aviv Sourasky Medical Center |
ClinicalTrials.gov Identifier: | NCT00633802 |
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 |
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Borderlone Personality Disorder |
Drug: Risperidone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
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 |
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2: Placebo Comparator |
Drug: Risperidone
1 mg/d risperidone for 10 weeks or placebo
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1: Experimental |
Drug: Risperidone
1 mg/d risperidone for 10 weeks or placebo
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Tel-Aviv Sourasky Medical Center ( Miki Bloch ) |
Study ID Numbers: | 04-089 |
Study First Received: | March 4, 2008 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00633802 History of Changes |
Health Authority: | Israel: Ethics Commission |
Risperidone Borderlone Personality Disorder |
Neurotransmitter Agents Dopamine Tranquilizing Agents Mental Disorders Psychotropic Drugs Risperidone |
Central Nervous System Depressants Dopamine Agents Antipsychotic Agents Borderline Personality Disorder Serotonin Personality Disorders |
Neurotransmitter Agents Tranquilizing Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Risperidone Central Nervous System Depressants Dopamine Antagonists Borderline Personality Disorder |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Mental Disorders Therapeutic Uses Dopamine Agents Central Nervous System Agents Personality Disorders |