Sponsor study identifier
interventional
30
1 country
1
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedPersonality 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
March 4, 2008
Actual (reported)March 12, 2008
Actual (reported)April 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Clinical Global Improvement Scale
0, 1, 5, 10 week
1 mg/d risperidone for 10 weeks or placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Psychiatric Service, Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
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.
Miki Bloch, Ph.D.
The Tel-Aviv Sourasky Medical Center
First Submitted
March 4, 2008
First Posted
March 12, 2008
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2009
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 12, 2008
Record last verified: 2008-03
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Source: ClinicalTrials.gov.
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