Ziprasidone in the Treatment of Borderline Personality Disorder - Full Text View

Sponsors and Collaborators:	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Fondo deInvestigación Sanitaria (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

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ziprasidone in the Treatment of Borderline Personality Disorder: A Double-Blind, Placebo-Controlled, Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Personality Disorders

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

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

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

Fondo deInvestigación Sanitaria (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 National Clinical Trials Identifier (NCT ID):

Pascual JC, Soler J, Puigdemont D, Pérez-Egea R, Tiana T, Alvarez E, Pérez V. Ziprasidone in the treatment of borderline personality disorder: a double-blind, placebo-controlled, randomized study. J Clin Psychiatry. 2008 Apr;69(4):603-8.

Responsible Party:	Víctor Pérez Sola ( Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau )
Study ID Numbers:	HSP-2003-002, HSP-2003-002
Study First Received:	March 11, 2008
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00635921 History of Changes
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

Study placed in the following topic categories:

Neurotransmitter Agents
Dopamine
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs
Central Nervous System Depressants

Dopamine Agents
Antipsychotic Agents
Ziprasidone
Borderline Personality Disorder
Serotonin
Personality Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Borderline Personality Disorder
Antipsychotic Agents

Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Ziprasidone
Central Nervous System Agents
Personality Disorders

ClinicalTrials.gov processed this record on September 10, 2009