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

Primary Purpose

Borderlone Personality Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Risperidone
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderlone Personality Disorder focused on measuring Risperidone, Borderlone Personality Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Psychiatric Service, Tel-Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Outcomes

Primary Outcome Measures

Clinical Global Improvement Scale

Secondary Outcome Measures

Full Information

First Posted
March 4, 2008
Last Updated
March 11, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00633802
Brief Title
Low-Dose Risperidone Treatment for Subjects Suffering From Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderlone Personality Disorder
Keywords
Risperidone, Borderlone Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
1 mg/d risperidone for 10 weeks or placebo
Primary Outcome Measure Information:
Title
Clinical Global Improvement Scale
Time Frame
0, 1, 5, 10 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with Borderline PD according to DSM-IV Signed informed consent. Age 18-45. Exclusion Criteria: Psychotic disorders (past or present). Substance or alcohol related disorders (past or present). Current major depressive episode. Suicidal risk. History of head trauma, which caused loss of consciousness or peritraumatic amnesia or necessitated hospitalization. Any known psychiatric or general medical condition currently requiring specific medical attention. Current treatment with any antipsychotic, antidepressant drugs or mood stabilizers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miki Bloch, Ph.D.
Phone
972-3-6974568
Email
mikib@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miki Bloch, Ph.D.
Organizational Affiliation
The Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Service, Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miki Bloch, Ph.D.
Phone
972-3-6974568
First Name & Middle Initial & Last Name & Degree
Miki Bloch, Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
36375174
Citation
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.
Results Reference
derived

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

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