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

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254748
• Other study ID #: D1441C00003
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2005
• Last updated: June 9, 2009
• Start date: June 2004
• Est. completion date: June 2007

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Drug:
• Quetiapine fumarate
flexible doses from 200 mg to 600 mg
• Placebo
placebo

Locations

Country	Name	City	State
Netherlands	Research Site	Apeldoorn
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Veghel

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

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