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Ziprasidone in the Treatment of Borderline Personality Disorder

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00635921
Enrollment
60
Registered
2008-03-14
Start date
2004-03-31
Completion date
2006-04-30
Last updated
2008-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder, ziprasidone

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.

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.

Interventions

DRUGziprasidone

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

DRUGPlacebo

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

Sponsors

Ministry of Health, Spain
CollaboratorOTHER_GOV
REM-TAP Network
CollaboratorUNKNOWN
Pfizer
CollaboratorINDUSTRY
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frame
CGI scale for use in borderline personality disorder (CGI-BPD)12 weeks

Secondary

MeasureTime frame
Hamilton Rating Scale for Anxiety (HAM-A)12 weeks
Brief Psychiatric Rating Scale (BPRS)12 weeks
SCL-90-R12 weeks
Barratt Impulsiveness Scale12 weeks
Hamilton Rating Scale Depression (HAM-D-17)12 weeks
UKU Side Effect Rating Scale12 weeks
EKG and laboratory assessment12 weeks
Buss-Durkee Inventory12 weeks
Treatment-emergent adverse events12 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026