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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00254748
First received: November 15, 2005
Last updated: June 9, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Borderline Personality Disorder
 Drug: Quetiapine fumarate
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: June 2004
Study Completion Date: June 2007
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Drug: Placebo
placebo
Experimental: 2
Flexible doses of 200 mg/day to 600 mg/day quetiapine fumarate
 Drug: Quetiapine fumarate
flexible doses from 200 mg to 600 mg
Other Names:
  • Seroquel
  • 204,636

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254748

Locations
Netherlands
Research Site
Apeldoorn, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Veghel, Netherlands
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00254748     History of Changes
Other Study ID Numbers: D1441C00003
Study First Received: November 15, 2005
Last Updated: June 9, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:
Borderline personality disorder

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013