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Ziprasidone in the Treatment of Borderline Personality Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00635921
First Posted: March 14, 2008
Last Update Posted: March 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
March 11, 2008
March 14, 2008
March 14, 2008
March 2004
April 2006   (Final data collection date for primary outcome measure)
CGI scale for use in borderline personality disorder (CGI-BPD) [ Time Frame: 12 weeks ]
Same as current
No Changes Posted
  • Hamilton Rating Scale Depression (HAM-D-17) [ Time Frame: 12 weeks ]
  • Hamilton Rating Scale for Anxiety (HAM-A) [ Time Frame: 12 weeks ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 12 weeks ]
  • SCL-90-R [ Time Frame: 12 weeks ]
  • Barratt Impulsiveness Scale [ Time Frame: 12 weeks ]
  • Treatment-emergent adverse events [ Time Frame: 12 weeks ]
  • UKU Side Effect Rating Scale [ Time Frame: 12 weeks ]
  • EKG and laboratory assessment [ Time Frame: 12 weeks ]
  • Buss-Durkee Inventory [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
Ziprasidone in the Treatment of Borderline Personality Disorder
Ziprasidone in the Treatment of Borderline Personality Disorder: A Double-Blind, Placebo-Controlled, Randomized Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Borderline Personality Disorder
  • Drug: ziprasidone
    Dose flexible from 40 to 200 mg/d during 12 weeks
  • Drug: Placebo
    flexible doses from 40 to 200 mg/d during 12 weeks
  • Active Comparator: I ziprasidone
    Intervention: Drug: ziprasidone
  • Placebo Comparator: II placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2006
April 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00635921
HSP-2003-002
HSP-2003-002
Yes
Not Provided
Not Provided
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Víctor Pérez Sola
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Ministry of Health, Spain
  • REM-TAP Network
  • Pfizer
Not Provided
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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