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Completed

NCT Number: NCT00635921

Ziprasidone in the Treatment of Borderline Personality Disorder

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry, Sta. Creu and St. Pau Hospital

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ziprasidone

Drug

Dose flexible from 40 to 200 mg/d during 12 weeks

Placebo

Drug

flexible doses from 40 to 200 mg/d during 12 weeks

Primary outcomes

  1. CGI scale for use in borderline personality disorder (CGI-BPD)

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Ministry of Health, Spain
  • Pfizer
  • REM-TAP Network

Registry information

Official study title

Ziprasidone in the Treatment of Borderline Personality Disorder: A Double-Blind, Placebo-Controlled, Randomized Study

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Mar 14, 2008
Registry last updated
Mar 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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