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Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Quetiapine fumarate
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline personality disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with BPD according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)/Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) including criterion 9: transient, stress related paranoid ideation or severe dissociative symptoms. In- or outpatients Exclusion Criteria: Depressive disorder Bipolar disorder Schizoaffective disorder/schizophrenia/delusional disorder/schizotypal personality disorder Alcohol- or substance dependence Quetiapine doses >100mg od use in the past Somatic: History of trauma capitis Visual and auditive disorders Neurological disorders (epilepsy) Pregnancy No adequate contraception History of cardial complaints/cardiological disorder Known sensitivity for quetiapine

Sites / Locations

  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Placebo

Flexible doses of 200 mg/day to 600 mg/day quetiapine fumarate

Outcomes

Primary Outcome Measures

To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms

Secondary Outcome Measures

To explore the effect of quetiapine on mood, anger, impulsiveness, hostility and anxiety in patients with BPD

Full Information

First Posted
November 15, 2005
Last Updated
June 9, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00254748
Brief Title
Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients
Official Title
The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
In patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective in the treatment of psychosis. In patients with borderline personality disorder (BPD), as far as the investigators know, no well designed controlled studies have been performed on the effect of one of the newer atypical antipsychotics on psychotic symptoms. It is of interest to investigate the benefit of quetiapine treatment in these types of patients. Quetiapine possibly gives less side-effects because of the expected lack of elevated prolactin levels, which is of importance in this patient group, overrepresented by young females. In this double blind, randomized, placebo controlled, 8 week, parallel group, multi-center study, quetiapine (in flexible doses between 200 mg/day and 600 mg/day) will be compared with the placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Borderline personality disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Flexible doses of 200 mg/day to 600 mg/day quetiapine fumarate
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Other Intervention Name(s)
Seroquel, 204,636
Intervention Description
flexible doses from 200 mg to 600 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms
Time Frame
assessed at each visit for 8 weeks
Secondary Outcome Measure Information:
Title
To explore the effect of quetiapine on mood, anger, impulsiveness, hostility and anxiety in patients with BPD
Time Frame
assessed at each visit for 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with BPD according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)/Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) including criterion 9: transient, stress related paranoid ideation or severe dissociative symptoms. In- or outpatients Exclusion Criteria: Depressive disorder Bipolar disorder Schizoaffective disorder/schizophrenia/delusional disorder/schizotypal personality disorder Alcohol- or substance dependence Quetiapine doses >100mg od use in the past Somatic: History of trauma capitis Visual and auditive disorders Neurological disorders (epilepsy) Pregnancy No adequate contraception History of cardial complaints/cardiological disorder Known sensitivity for quetiapine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Netherlands Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Apeldoorn
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
Country
Netherlands
Facility Name
Research Site
City
Veghel
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
36375174
Citation
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.
Results Reference
derived

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Verkes Borderline Study: The Effect of Quetiapine on Borderline Personality Disordered Patients

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