Ziprasidone in the Treatment of Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Spain
REM-TAP Network
Pfizer
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT00635921
First received: March 11, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention Phase
Borderline Personality Disorder
Drug: ziprasidone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Ziprasidone in the Treatment of Borderline Personality Disorder: A Double-Blind, Placebo-Controlled, Randomized Study

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • CGI scale for use in borderline personality disorder (CGI-BPD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Rating Scale Depression (HAM-D-17) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Hamilton Rating Scale for Anxiety (HAM-A) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • SCL-90-R [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Barratt Impulsiveness Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • UKU Side Effect Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • EKG and laboratory assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Buss-Durkee Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00635921

Locations
Spain
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
Pfizer
  More Information

No publications provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Additional 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, HSP-2003-002
Study First Received: March 11, 2008
Last Updated: March 11, 2008
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ministry of Health

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

Additional relevant MeSH terms:
Borderline Personality Disorder
Disease
Personality Disorders
Mental Disorders
Pathologic Processes
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014