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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633802
Recruitment Status : Unknown
Verified March 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : March 12, 2008
Last Update Posted : March 12, 2008
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Borderlone Personality Disorder Drug: Risperidone Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2004
Estimated Primary Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Clinical Global Improvement Scale [ Time Frame: 0, 1, 5, 10 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00633802

Contact: Miki Bloch, Ph.D. 972-3-6974568

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

Responsible Party: Miki Bloch, Tel-Aviv Sourasky Medical Center Identifier: NCT00633802     History of Changes
Other Study ID Numbers: 04-089
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: March 12, 2008
Last Verified: March 2008

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

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents