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Completed

NCT Number: NCT00254748

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

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.

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Apeldoorn, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine fumarate

Drug

flexible doses from 200 mg to 600 mg

Other names: Seroquel, 204,636

Placebo

Drug

placebo

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Nov 17, 2005
Registry last updated
Jun 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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