NCT00254748

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2004

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

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

June 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

First QC Date

November 15, 2005

Last Update Submit

June 9, 2009

Conditions

Borderline Personality Disorder

Keywords

Borderline personality disorder

Outcome Measures

Primary Outcomes (1)

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

    assessed at each visit for 8 weeks

Secondary Outcomes (1)

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

    assessed at each visit for 8 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

EXPERIMENTAL

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

Drug: Quetiapine fumarate

Interventions

Quetiapine fumarateDRUG

flexible doses from 200 mg to 600 mg

Also known as: Seroquel, 204,636
2
PlaceboDRUG

placebo

1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Apeldoorn, Netherlands

Location

Research Site

Nijmegen, Netherlands

Location

Research Site

Veghel, Netherlands

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • AstraZeneca Netherlands Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

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
INDUSTRY

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 17, 2005

Study Start

June 1, 2004

Study Completion

June 1, 2007

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

NL(3)