NCT00635921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
Last Updated

March 14, 2008

Status Verified

March 1, 2008

Enrollment Period

2.1 years

First QC Date

March 11, 2008

Last Update Submit

March 11, 2008

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorderziprasidone

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

I ziprasidone

ACTIVE COMPARATOR
Drug: ziprasidone

II placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ziprasidoneDRUG

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

I ziprasidone
PlaceboDRUG

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

II placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV diagnosis of Borderline Personality Disorder
  • Age between 18 and 45 years
  • Clinical Global Impression of Severity (CGI-S)scores \>4

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Barcelona, 08025, Spain

Location

Related Publications (2)

  • Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.

    PMID: 36375174DERIVED

  • Pascual JC, Soler J, Puigdemont D, Perez-Egea R, Tiana T, Alvarez E, Perez 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. doi: 10.4088/jcp.v69n0412.

    PMID: 18251623DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 14, 2008

Study Start

March 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

March 14, 2008

Record last verified: 2008-03

Locations

ES(1)