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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Borderline Personality Disorder

Intervention: Quetiapine fumarate (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Netherlands Medical Director, MD, Study Director, Affiliation: AstraZeneca


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.

Clinical Details

Official title: The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

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


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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


- Alcohol- or substance dependence

- Quetiapine doses >100mg od use in the past


- 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

Locations and Contacts

Research Site, Apeldoorn, Netherlands

Research Site, Nijmegen, Netherlands

Research Site, Veghel, Netherlands

Additional Information

Starting date: June 2004
Last updated: June 9, 2009

Page last updated: August 23, 2015

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