Ziprasidone in the Treatment of Borderline Personality Disorder

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Drug: ziprasidone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I ziprasidone<br> | Drug: ziprasidone<br>* Dose flexible from 40 to 200 mg/d during 12 weeks<br>|
| Placebo Comparator: II placebo<br> | Drug: Placebo<br>* flexible doses from 40 to 200 mg/d during 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI scale for use in borderline personality disorder (CGI-BPD) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale Depression (HAM-D-17) |  | 12 weeks | 
| Hamilton Rating Scale for Anxiety (HAM-A) |  | 12 weeks | 
| Brief Psychiatric Rating Scale (BPRS) |  | 12 weeks | 
| SCL-90-R |  | 12 weeks | 
| Barratt Impulsiveness Scale |  | 12 weeks | 
| Treatment-emergent adverse events |  | 12 weeks | 
| UKU Side Effect Rating Scale |  | 12 weeks | 
| EKG and laboratory assessment |  | 12 weeks | 
| Buss-Durkee Inventory |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Borderline Personality Disorder, ziprasidone