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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254748
First Posted: November 17, 2005
Last Update Posted: June 11, 2009
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.
Information provided by:
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00254748     History of Changes
Other Study ID Numbers: D1441C00003
First Submitted: November 15, 2005
First Posted: November 17, 2005
Last Update Posted: June 11, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
Borderline personality disorder

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