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Ziprasidone in the Treatment of 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.
ClinicalTrials.gov Identifier: NCT00635921
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : March 14, 2008
Information provided by:

Study Description
Brief Summary:

Objective: The aim of this double-blind, placebo-controlled study was to evaluate the efficacy and tolerability of ziprasidone in the treatment of adult patients with Borderline Personality Disorder (BPD).

Method: Sixty BPD patients were included in a 12-week, single-center, double-blind, placebo-controlled study. The subjects were randomly assigned to ziprasidone or placebo in a 1:1 ratio following a two-week baseline period. The Clinical Global Impression scale for use in BPD patients (CGI-BPD) was the primary outcome measure, and other scales and self-reports related to affect, behavior, psychosis, general psychopathology domains and clinical safety were included.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: ziprasidone Drug: Placebo Phase 2

Detailed Description:

The American Psychiatric Association (APA) Guidelines for the Treatment of Borderline personality disorder recommend that pharmacological treatment for BPD has an important adjunctive role, especially for diminution of symptoms such as affective instability, impulsivity, psychotic-like symptoms, and self-destructive behavior. Studies conducted with low doses of conventional antipsychotics have showed significant improvements in specific symptoms such as hostility, impulsiveness, mood, and psychotic symptoms.

The introduction of atypical antipsychotics, with a more favorable tolerance profile, increases clinicians' options for treating BPD. Olanzapine has proven its efficacy in four double-blind, placebo-controlled clinical trials in patients with BPD. Ziprasidone is an atypical antipsychotic with a pharmacological action on serotonergic, dopaminergic and adrenergic receptors. It has proven to be effective for schizophrenia, schizoaffective and acute mania disorders and the incidence of side effects is low.

Although clinical findings and the pharmacological activity of ziprasidone suggest the drug may have therapeutic benefits in BPD patients, no controlled studies have yet been conducted in these patients. We carried out a randomized, double-blind, placebo-controlled study to evaluate efficacy and tolerability of ziprasidone in the management of BPD patients with moderate-high clinical severity.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ziprasidone in the Treatment of Borderline Personality Disorder: A Double-Blind, Placebo-Controlled, Randomized Study
Study Start Date : March 2004
Primary Completion Date : April 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: I ziprasidone Drug: ziprasidone
Dose flexible from 40 to 200 mg/d during 12 weeks
Placebo Comparator: II placebo Drug: Placebo
flexible doses from 40 to 200 mg/d during 12 weeks

Outcome Measures

Primary Outcome Measures :
  1. CGI scale for use in borderline personality disorder (CGI-BPD) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Hamilton Rating Scale Depression (HAM-D-17) [ Time Frame: 12 weeks ]
  2. Hamilton Rating Scale for Anxiety (HAM-A) [ Time Frame: 12 weeks ]
  3. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 12 weeks ]
  4. SCL-90-R [ Time Frame: 12 weeks ]
  5. Barratt Impulsiveness Scale [ Time Frame: 12 weeks ]
  6. Treatment-emergent adverse events [ Time Frame: 12 weeks ]
  7. UKU Side Effect Rating Scale [ Time Frame: 12 weeks ]
  8. EKG and laboratory assessment [ Time Frame: 12 weeks ]
  9. Buss-Durkee Inventory [ Time Frame: 12 weeks ]

Eligibility Criteria

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

Inclusion Criteria:

  • DSM-IV diagnosis of Borderline Personality Disorder
  • Age between 18 and 45 years
  • Clinical Global Impression of Severity (CGI-S)scores >4

Exclusion Criteria:

  • No comorbidity with schizophrenia, drug-induced psychosis, organic brain syndrome, alcohol or other substance dependence, bipolar disorder, mental retardation, or major depressive episode in course
  • current use of medically accepted contraception in the case of female patients.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00635921

Department of Psychiatry, Sta. Creu and St. Pau Hospital
Barcelona., Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Ministry of Health, Spain
REM-TAP Network
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Víctor Pérez Sola
ClinicalTrials.gov Identifier: NCT00635921     History of Changes
Other Study ID Numbers: HSP-2003-002
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: March 14, 2008
Last Verified: March 2008

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Borderline Personality Disorder

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
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