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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00633802
First received: March 4, 2008
Last updated: March 11, 2008
Last verified: March 2008
  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

Resource links provided by NLM:


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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 August 01, 2014