NCT00633802

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

Enrollment Period

5 years

First QC Date

March 4, 2008

Last Update Submit

March 11, 2008

Conditions

Borderlone Personality Disorder

Keywords

RisperidoneBorderlone Personality Disorder

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Improvement Scale

    0, 1, 5, 10 week

Study Arms (2)

2

PLACEBO COMPARATOR
Drug: Risperidone

1

EXPERIMENTAL
Drug: Risperidone

Interventions

RisperidoneDRUG

1 mg/d risperidone for 10 weeks or placebo

12

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with Borderline PD according to DSM-IV
  • Signed informed consent.
  • Age 18-45.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Service, Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36375174DERIVED

MeSH Terms

Interventions

Risperidone

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Miki Bloch, Ph.D.

    The Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miki Bloch, Ph.D.

CONTACT

972-3-6974568mikib@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 12, 2008

Study Start

April 1, 2004

Primary Completion

April 1, 2009

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

IL(1)