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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00254748

Enrollment

Registered

2005-11-17

Start date

2004-06-30

Completion date

2007-06-30

Last updated

2009-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

Keywords

Borderline personality disorder

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.

Interventions

DRUGQuetiapine fumarate

flexible doses from 200 mg to 600 mg

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To explore the effect of quetiapine on mood, anger, impulsiveness, hostility and anxiety in patients with BPD	assessed at each visit for 8 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026