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

This study is currently recruiting participants.
Verified by Tel-Aviv Sourasky Medical Center, March 2008

Sponsored by: Tel-Aviv Sourasky Medical Center
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00633802
  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

MedlinePlus related topics:   Personality Disorders   

Drug Information available for:   Risperidone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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
2: Placebo Comparator Drug: Risperidone
1 mg/d risperidone for 10 weeks or placebo
1: Experimental 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

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633802

Contacts
Contact: Miki Bloch, Ph.D.     972-3-6974568     mikib@tasmc.health.gov.il    

Locations
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.            

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Investigators
Principal Investigator:     Miki Bloch, Ph.D.     The Tel-Aviv Sourasky Medical Center    
  More Information


Responsible Party:   Tel-Aviv Sourasky Medical Center ( Miki Bloch )
Study ID Numbers:   04-089
First Received:   March 4, 2008
Last Updated:   March 11, 2008
ClinicalTrials.gov Identifier:   NCT00633802
Health Authority:   Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
Risperidone  
Borderlone Personality Disorder  

Study placed in the following topic categories:
Dopamine
Mental Disorders
Risperidone
Borderline Personality Disorder
Serotonin
Personality Disorders

Additional relevant MeSH terms:
Disease
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on December 10, 2008




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